Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding

  • Review
  • Intervention

Authors


Abstract

Background

Heavy menstrual bleeding (HMB), which includes both menorrhagia and metrorrhagia, is an important cause of ill health in women. Surgical treatment of HMB often follows failed or ineffective medical therapy. The definitive treatment is hysterectomy, but this is a major surgical procedure with significant physical and emotional complications, as well as social and economic costs. Several less invasive surgical techniques (e.g. transcervical resection of the endometrium (TCRE), laser approaches) and various methods of endometrial ablation have been developed with the purpose of improving menstrual symptoms by removing or ablating the entire thickness of the endometrium.

Objectives

The objective of this review is to compare the effectiveness, acceptability and safety of techniques of endometrial destruction by any means versus hysterectomy by any means for the treatment of heavy menstrual bleeding.

Search methods

Electronic searches for relevant randomised controlled trials (RCTs) targeted but were not limited to the following: the Cochrane Menstrual Disorders and Subfertility Group Register of Trials, MEDLINE, EMBASE, PsycINFO and the Cochrane CENTRAL register of trials. Attempts were made to identify trials by examining citation lists of review articles and guidelines and by performing handsearching. Searches were performed in 2007, 2008 and 2013.

Selection criteria

Included in the review were any RCTs that compared techniques of endometrial destruction by any means with hysterectomy by any means for the treatment of heavy menstrual bleeding in premenopausal women.

Data collection and analysis

Two review authors independently searched for studies, extracted data and assessed risk of bias. Risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes were estimated from the data. Outcomes analysed included improvement in menstrual blood loss, satisfaction, change in quality of life, duration of surgery and hospital stay, time to return to work, adverse events and requirements for repeat surgery due to failure of the initial surgical treatment.

Main results

Eight RCTs that fulfilled the inclusion criteria for this review were identified. For two trials, the review authors identified multiple publications that assessed different outcomes at different postoperative time points for the same women.

An advantage in favour of hysterectomy compared with endometrial ablation was observed in various measures of improvement in bleeding symptoms and satisfaction rates. A slightly lower proportion of women who underwent endometrial ablation perceived improvement in bleeding symptoms at one year (RR 0.89, 95% confidence interval (CI) 0.85 to 0.93, four studies, 650 women, I2 = 31%), at two years (RR 0.92, 95% CI 0.86 to 0.99, two studies, 292 women, I2 = 53%) and at four years (RR 0.93, 95% CI 0.88 to 0.99, two studies, 237 women, I2 = 79%). The same group of women also showed improvement in pictorial blood loss assessment chart (PBAC) score at one year (MD 24.40, 95% CI 16.01 to 32.79, one study, 68 women) and at two years (MD 44.00, 95% CI 36.09 to 51.91, one study, 68 women). Repeat surgery resulting from failure of the initial treatment was more likely to be needed after endometrial ablation than after hysterectomy at one year (RR 14.9, 95% CI 5.2 to 42.6, six studies, 887 women, I2 = 0%), at two years (RR 23.4, 95% CI 8.3 to 65.8, six studies, 930 women, I2 = 0%), at three years (RR 11.1, 95% CI 1.5 to 80.1, one study, 172 women) and at four years (RR 36.4, 95% CI 5.1 to 259.2, one study, 197 women). Most adverse events, both major and minor, were significantly more likely after hysterectomy during hospital stay. Women who had a hysterectomy were more likely to experience sepsis (RR 0.2, 95% CI 0.1 to 0.3, four studies, 621 women, I2 = 62%), blood transfusion (RR 0.2, 95% CI 0.1 to 0.6, four studies, 751 women, I2 = 0%), pyrexia (RR 0.2, 95% CI 0.1 to 0.4, three studies, 605 women, I2 = 66%), vault haematoma (RR 0.1, 95% CI 0.04 to 0.3, five studies, 858 women, I2 = 0%) and wound haematoma (RR 0.03, 95% CI 0.00 to 0.5, one study, 202 women) before hospital discharge. After discharge from hospital, the only difference that was reported for this group was a higher rate of infection (RR 0.2, 95% CI 0.1 to 0.5, one study, 172 women).

For some outcomes (such as a woman’s perception of bleeding and proportion of women requiring further surgery for HMB), a low GRADE score was generated, suggesting that further research in these areas is likely to change the estimates.

Authors' conclusions

Endometrial resection and ablation offers an alternative to hysterectomy as a surgical treatment for heavy menstrual bleeding. Both procedures are effective, and satisfaction rates are high. Although hysterectomy is associated with longer operating time (particularly for the laparoscopic route), a longer recovery period and higher rates of postoperative complications, it offers permanent relief from heavy menstrual bleeding. The initial cost of endometrial destruction is significantly lower than that of hysterectomy, but, because retreatment is often necessary, the cost difference narrows over time.

Résumé scientifique

Résection et ablation de l'endomètre versus hystérectomie pour saignements menstruels abondants

Contexte

Les saignements menstruels abondants (HMB), qui comprennent la ménorragie et la métrorragie, sont une cause importante de mauvaise santé chez les femmes. Le traitement chirurgical des SMA fait souvent suite à l'échec ou à l'inefficacité du traitement médical. Le traitement définitif est l'hystérectomie, mais il s’agit d’une procédure chirurgicale majeure présentant des complications physiques et psychologiques, ainsi que des coûts sociaux et économiques. Plusieurs techniques chirurgicales moins invasives (par exemple la résection transcervicale de l'endomètre, ou les approches à base de laser) et différentes méthodes d'ablation de l'endomètre ont été développées dans le but d'améliorer les symptômes menstruels par le retrait ou l’ablation de toute l'épaisseur de l'endomètre.

Objectifs

L'objectif de cette revue est de comparer l'efficacité, l'acceptabilité et l'innocuité des techniques de destruction de l'endomètre, quelles qu’elles soient, versus l’hystérectomie, pour le traitement des saignements menstruels abondants.

Stratégie de recherche documentaire

Les recherches électroniques d'essais contrôlés randomisés (ECR) pertinents ciblaient mais n'étaient pas limitées aux sources suivantes : le registre d’essais du groupe Cochrane sur les troubles menstruels et l'hypofertilité, MEDLINE, EMBASE, PsycINFO et le registre Cochrane CENTRAL. Des tentatives ont été faites pour identifier des essais en examinant les références bibliographiques d'articles de revue et de guidelines et à l'aide d'une recherche manuelle. Des recherches ont été effectuées en 2007, 2008 et 2013.

Critères de sélection

Les ECR inclus dans la revue comparaient toutes techniques de destruction de l'endomètre par rapport à l'hystérectomie, dans le traitement des saignements menstruels abondants chez les femmes préménopausées.

Recueil et analyse des données

Deux auteurs de revue ont recherché des études, extrait les données et évalué le risque de biais. Les risques relatifs (RR) pour les résultats dichotomiques et les différences moyennes (DM) pour les résultats continus ont été estimés à partir des données. Les critères de résultat analysés comprenaient l'amélioration des pertes de sang menstruelles, la satisfaction, les changements dans la qualité de vie, la durée de l'opération et de l'hospitalisation, le délai de retour au travail, les événements indésirables et les besoins d'une nouvelle intervention chirurgicale en raison d'échec du traitement chirurgical initial.

Résultats principaux

Huit ECR ont été identifiés qui remplissaient les critères d'inclusion de cette revue. Pour deux essais, les auteurs de la revue ont identifié plusieurs publications ayant évalué différents critères de jugement à différents points temporels postopératoire pour les mêmes femmes.

Un avantage en faveur de l'hystérectomie par rapport à l'ablation de l'endomètre était observé dans les différentes mesures de l'amélioration des symptômes de saignements et les taux de satisfaction. Une proportion légèrement plus faible de femmes ayant subi une ablation de l'endomètre ont perçu une amélioration des symptômes de saignements à un an (RR 0,89, intervalle de confiance (IC) à 95% 0,85 à 0,93, quatre études, 650 femmes, I2 =31%), à deux ans (RR 0,92, IC à 95% 0,86 à 0,99, deux études, 292 femmes, I2 =53%) et à quatre ans (RR 0,93, IC à 95% 0,88 à 0,99, deux études, 237 femmes, I2 =79%). Le même groupe de femmes a également montré une amélioration du score d'évaluation graphique des pertes de sang (PBAC) à un an (DM 24,40, IC à 95% 16.01 à 32.79, une étude, 68 femmes) et à deux ans (DM 44.00, IC à 95% 36.09 à 51.91, une étude, 68 femmes). Une nouvelle intervention chirurgicale résultant d'échec du traitement initial était plus susceptible d'être nécessaire après ablation de l'endomètre qu'après hystérectomie à un an (RR de 14,9 ; IC à 95%, entre 5,2 et 42,6, six études, 887 femmes, I2 =0%), à deux ans (RR 23,4, IC à 95%, entre 8,3 à 65,8, six études, 930 femmes, I2 =0%), au bout de trois ans (RR 11,1, IC à 95%, entre 1,5 à 80,1, une étude, 172 femmes) et à quatre ans (RR 36,4, IC à 95% 5,1 pour 259,2, une étude, 197 femmes). La plupart des événements indésirables, tant majeurs que mineurs, ont été significativement plus fréquents après hystérectomie au cours du séjour à l'hôpital. Les femmes ayant subi une hystérectomie étaient plus susceptibles de présenter une septicémie (RR 0,2, IC à 95% entre 0,1 et 0,3, quatre études, 621 femmes, I 2 =62%), une transfusion sanguine (RR 0,2, IC à 95% entre 0,1 et 0,6, quatre études, 751 femmes, I2 =0%), une fièvre (RR 0,2, IC à 95% entre 0,1 et 0,4, trois études, 605 femmes, I2 =66%), un hématome de la voute vaginale (RR de 0,1, IC à 95% 0,04 à 0,3, cinq études, 858 femmes, I 2 =0%) et un hématome de la plaie (RR de 0,03, IC à 95% 0,00 à 0,5, une étude, 202 femmes) avant la sortie d'hôpital. Après la sortie d'hôpital, la seule différence rapportée pour ce groupe était un taux plus élevé d'infection (RR 0,2, IC à 95% entre 0,1 et 0,5, une étude, 172 femmes).

Pour certains critères de jugement (comme la perception des saignements et la proportion de femmes nécessitant une intervention chirurgicale supplémentaire pour les SMA), un faible score GRADE a été généré, ce qui suggère que des recherches supplémentaires sont susceptibles de modifier les estimations.

Conclusions des auteurs

La résection et l’ablation de l'endomètre offrent une alternative à l'hystérectomie comme traitement chirurgical des saignements menstruels abondants. Les deux procédures sont efficaces, et leurs taux de satisfaction sont élevés. Bien que l'hystérectomie soit associée à une plus longue durée d'opération (en particulier pour le traitement par voie laparoscopique), une plus longue période de récupération et des taux plus élevés de complications post-opératoires, elle permet de se débarrasser définitivement des saignements menstruels abondants. Le coût initial de la destruction de l'endomètre est significativement plus faible que celui de l'hystérectomie, mais en raison d’une reprise du traitement souvent nécessaire, la différence de coût s'amoindrit au fil du temps.

Plain language summary

A comparison of the effectiveness and safety of two different surgical treatments for heavy menstrual bleeding

Review question

This Cochrane review concerns women with heavy menstrual bleeding (HMB), which is menstrual blood loss that a woman feels to be excessive and that often interferes with her quality of life. Researchers from The Cochrane Collaboration compared endometrial resection or ablation versus hysterectomy for women with HMB. The main factors (thought to be of greatest importance) were how well each operation was able to treat the symptoms of HMB, how women felt about undergoing each operation and what the complication rates were. Additional factors studied were how long each operation took to perform, how long women took to recover from the operation and how much the operation cost the hospital and the woman herself.

Background

Surgical treatments for HMB include removal or destruction of the inside lining (endometrium) of the womb (endometrial resection or ablation) and surgical removal of the whole womb (hysterectomy). Both methods are commonly offered by gynaecologists, usually but not always after a non-surgical treatment has failed to correct the problem. Endometrial resection/ablation is performed via the entrance to the womb, without the need for a surgical cut. During a hysterectomy, the uterus can be removed via a surgical cut to the abdomen, via the vagina, or via 'keyhole' surgery that involves very small surgical cuts to the abdomen (laparoscopy); this last approach is a newer way to perform hysterectomy. Hysterectomy is effective in permanently stopping HMB, but it stops fertility and is associated with all the risks of major surgery, including infection and blood loss. These risks are smaller with endometrial resection/ablation.

Search date

A systematic review of the research comparing endometrial resection and ablation versus hysterectomy for the treatment of heavy menstrual bleeding was most recently updated in October 2013 by researchers at The Cochrane Collaboration. After searching for all relevant studies, review authors included eight studies involving a total of 1,260 women.

Study characteristics

Only randomised controlled trials (RCTs) are included in Cochrane reviews. RCTs are studies in which participants are randomly allocated to one of two groups, each receiving a different intervention (in this case, endometrial ablation/resection or hysterectomy). The two groups are then compared. RCTs that compared these two interventions were included in this review if they studied women with HMB who had not gone through menopause and who did not have cancer or precancer of the uterus.

Key results and conclusions

The review of studies revealed that endometrial ablation/resection is an effective and possibly cheaper alternative to hysterectomy with faster recovery, although retreatment with additional surgery is sometimes needed. Hysterectomy is associated with more definitive resolution of symptoms but longer operating times and greater potential for surgical complications. For both operations, women generally reported that undergoing the procedure was acceptable and that they were satisfied with their experience.

Since laparoscopic hysterectomy has become more widely used, several of the previously described disadvantages of traditional types of hysterectomy have improved, and some outcomes such as duration of hospital stay, time to return to work and time to return to normal activities have become more comparable with those of endometrial ablation. However, laparoscopic hysterectomy is associated with longer operating time than other modes of hysterectomy and requires more sophisticated surgical expertise and equipment.

Only three of the eight trials included laparoscopic hysterectomy in their comparison. More trials in this area will be needed as this route of hysterectomy becomes more widely available.

Identifying harms

Both surgical treatments are considered to be generally safe, and low complication rates are reported. However, hysterectomy is associated with higher rates of infection and requirement for blood transfusion.

Quality of the evidence

Evidence reported in this review was occasionally of low quality, suggesting that further research is likely to change the result. This was the case for outcomes such as a woman’s perception of bleeding and proportion of women requiring further surgery for HMB.

Résumé simplifié

Une comparaison de l'efficacité et de l'innocuité de deux différents traitements chirurgicaux dans les saignements menstruels abondants

Question

Cette revue Cochrane s’intéresse aux femmes souffrant de problèmes de saignements menstruels abondants (SMA), définis comme des pertes de sang menstruel qu'une femme ressent comme étant excessives et qui souvent interfère avec sa qualité de vie. Les chercheurs de la Collaboration Cochrane ont comparé résection ou ablation de l'endomètre versus hystérectomie pour les femmes souffrant de SMA. Les principaux facteurs (supposés être de plus grande importance) étaient à quel point chaque opération était capable de traiter les symptômes de SMA, la manière dont les femmes se sentaient à l’idée de subir chaque opération et quels étaient les taux de complications. D'autres facteurs étudiés étaient la durée de réalisation des opérations, la durée nécessaire pour que les femmes se rétablissent après l'opération et le coût de l’opération pour l'hôpital et la femme elle-même.

Contexte

Les traitements chirurgicaux pour les SMA comprennent le retrait ou la destruction de la muqueuse interne (endomètre) de l'utérus (résection ou ablation de l'endomètre) et l'ablation chirurgicale de l'ensemble de l'utérus (hystérectomie). Les deux méthodes sont couramment proposées par gynécologistes, généralement mais pas toujours après l’échec d’un traitement non chirurgical. La résection/l’ablation de l'endomètre est réalisée via l'entrée de l'utérus, sans avoir recours à une incision chirurgicale. Au cours d'une hystérectomie, l'utérus peut être retiré par une incision chirurgicale sur l'abdomen, via le vagin, ou par une chirurgie à travers un orifice qui implique de très petites incisions chirurgicales dans l'abdomen (laparoscopie); cette dernière approche est une nouvelle méthode de réalisation d’une hystérectomie. L'hystérectomie est efficace pour arrêter définitivement les SMA, mais elle met un terme à la fertilité et est associée à tous les risques d'une intervention chirurgicale majeure, y compris d'infection et de perte de sang. Ces risques sont plus petits avec résection/ablation de l'endomètre.

Date de recherche

Une revue systématique des recherches comparant la résection et et l’ablation de l'endomètre versus l’hystérectomie pour le traitement des saignements menstruels abondants mise à jour en octobre 2013 par des chercheurs de la Collaboration Cochrane. Après avoir recherché toutes les études pertinentes, les auteurs de revue ont inclus huit études impliquant un total de 1 260 femmes.

Caractéristiques de l'étude

Seuls les essais contrôlés randomisés (ECR) sont inclus dans les revues Cochrane. Des ECR sont des études dans lesquelles les participants sont assignés de manière aléatoire à un des deux groupes, chaque groupe recevant une intervention différente (dans ce cas, soit une ablation/résection soit une hystérectomie). Les deux groupes sont ensuite comparés. Les ECR comparant ces deux interventions ont été inclus dans cette revue s'ils étudiaient des femmes souffrant de SMA qui persistaient après la ménopause et qui n’avaient pas eu de cancer ou de pré-cancer de l'utérus.

Résultats clés et conclusions

La revue des études a révélé que l’ablation/résection de l’endomètre est une alternative efficace et peut-être moins couteuse à l'hystérectomie avec une récupération plus rapide, bien qu’une intervention chirurgicale supplémentaire soit parfois nécessaire. L'hystérectomie est associée à plus de résolutions définitives des symptômes mais un allongement de la durée d’opération un plus grand risque de complications chirurgicales. Pour ces deux opérations, les femmes ont généralement rapporté que les deux procédures étaient acceptables et qu'elles étaient satisfaites de leur expérience.

Puisque l'hystérectomie laparoscopique est devenue plus courante, plusieurs des inconvénients préalablement décrits dans les méthodes traditionnelle d’hystérectomie ont été améliorés, et certains critères de jugement tels que la durée de séjour à l'hôpital, le délai de retour au travail et le délais de reprise des activités normales sont devenus plus comparables à ceux de l'ablation de l'endomètre. Cependant, l'hystérectomie laparoscopique est associé à une plus longue durée d'opération que d'autres modes d’hystérectomie et nécessite une expertise et un équipement chirurgical plus sophistiqués.

Seules trois des huit essais incluaient une hystérectomie laparoscopique dans leur comparaison. Des essais supplémentaires dans ce domaine seront nécessaires pour que cette voie d’hystérectomie devienne plus largement disponible.

Repérer les effets délétères

Les deux traitements chirurgicaux sont considérées comme étant généralement sans danger, et de faibles taux de complications sont rapportés. Cependant, l'hystérectomie est associée à une augmentation des taux d'infection et du recours à une transfusion sanguine.

Qualité des preuves

Les preuves rapportées dans cette revue étaient parfois de faible qualité, ce qui suggère que des recherches supplémentaires sont susceptibles de modifier les résultats. Cela a été le cas pour les critères de jugement tels que la perception des saignements et la proportion de femmes nécessitant une intervention chirurgicale supplémentaire pour les SMA.

Notes de traduction

Traduit par: French Cochrane Centre 14th January, 2014
Traduction financée par: Instituts de Recherche en Sant� du Canada, Minist�re de la Sant� et des Services Sociaux du Qu�bec, Fonds de recherche du Qu�bec-Sant� et Institut National d'Excellence en Sant� et en Services Sociaux;

Summary of findings(Explanation)

Summary of findings for the main comparison. Endometrial resection/ablation for heavy menstrual bleeding
  1. 1Lack of blinding (although unfeasible) is likely to bias women's responses.
    2Significant heterogeneity.

    3Result suggests incomplete operation—rare.
    4Wide confidence interval.

Endometrial resection/ablation for heavy menstrual bleeding
Patient or population: women with heavy menstrual bleeding
Settings:
Intervention: endometrial resection/ablation
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Endometrial resection/ablation
Woman's perception (proportion with improvement in bleeding symptoms)—within one year of follow-up 978 per 1,000 890 per 1,000
(783 to 949)
RR 0.91
(0.8 to 0.97)
650
(4 studies)
⊕⊕⊝⊝
low 1,2
 
PBAC score (continuous data)—at one year of follow-up Mean PBAC score (continuous data) at one year of follow-up in the intervention groups was
24.4 higher
(16.01 to 32.79 higher)
 68
(1 study)
⊕⊕⊕⊝
moderate 1
 
Adverse eventsshort term (intraoperative and immediate postoperative)sepsis 319 per 1,000 61 per 1,000
(38 to 99)
RR 0.19
(0.12 to 0.31)
621
(4 studies)
⊕⊕⊕⊝
moderate 2
 
Proportion requiring further surgery for HMB—within one year after surgery 2 per 1,000 3 36 per 1,000
(13 to 103)
RR 14.94
(5.24 to 42.57)
887
(6 studies)
⊕⊕⊝⊝
low 1,4
 
Proportion satisfied with treatment—at one year of follow-up 820 per 1,000 771 per 1,000
(721 to 820)
RR 0.94
(0.88 to 1)
739
(4 studies)
⊕⊕⊕⊝
moderate 1
 
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.
GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Description of the condition

Heavy menstrual bleeding (HMB) is a common presenting complaint for primary care services and a frequent reason for secondary referral, with 5% of women between 30 and 49 years of age seeking medical attention for the problem (Vessey 1992; Cooper 2011).

Unacceptably problematic bleeding is most commonly determined by the woman herself if the amount or frequency of blood loss interferes with her physical or psychosocial well-being. This personal perception is often what determines the need for treatment and assessment of outcomes afterwards. 

Many alternative definitions for HMB are used, including menorrhagia, abnormal menstrual bleeding, abnormal uterine bleeding and disordered uterine bleeding. These terms have not always been universally defined, and considerable overlap and confusion between them have been noted in the existing literature (Woolcock 2008). In response to this confusion, the International Federation of Gynaecology and Obstetrics (FIGO) formally defined HMB as ‘the woman's perspective of increased menstrual volume, regardless of regularity, frequency, or duration’ (Munro 2011).

Intervention for HMB should be aimed at correction of identified underlying causes, control of bleeding, amelioration of anaemia and improvement in quality of life measures, with the woman’s contraceptive requirements or desire for future fertility taken into account, along with individual preferences for treatment. 

Description of the intervention

Many well-established treatment options for HMB are available, including hormonal and non-hormonal medications, but among women who do not desire future fertility or for whom medical treatment may be problematic, inconvenient or prolonged, surgical management may be preferred. 

Until the mid-1980s, hysterectomy was the only option for such women, and 60% of women presenting with HMB during this time underwent hysterectomy as a first-line treatment (NICE 2007). Hysterectomy continues to be performed via the more traditional abdominal and vaginal routes, but minimally invasive techniques have been introduced for women with benign disease, and these techniques continue to be developed. Such approaches include the introduction of laparoscopic hysterectomy (total laparoscopic hysterectomy and laparoscopically assisted vaginal hysterectomy) in 1989 (Reich 1989) and single-port laparoscopic hysterectomy in 2009 (Li 2012).

Considerable differences between types of approach have been noted with regard to intraoperative complications, duration of hospital stay, length of recovery and cost. However, as this review aims to compare hysterectomy with endometrial resection and ablation, the results for hysterectomy by all approaches will be pooled. 

Endometrial ablation is a minimally invasive hysteroscopic surgical intervention for HMB involving removal or destruction of the endometrium. Since it was introduced in the 1990s, its popularity as an alternative to hysterectomy has grown. An examination of the UK National Health Service (NHS) statistics in 2005 revealed that endometrial destruction was being performed more frequently than hysterectomy for benign HMB in the UK (Reid 2007).

Since its invention, techniques for endometrial resection and ablation have evolved considerably as technologies have advanced (Sharp 2012). Currently, no clear evidence of differences in effectiveness or safety between ‘first’- and ‘second’-generation techniques has been found (Lethaby 2005; Fernandez 2011).

‘First-generation’ techniques included desiccation of the endometrium by way of rollerball endometrial ablation (REA) and transcervical resection of the endometrium with loop electrode. These techniques require direct hysteroscopic vision throughout the procedure, whereby other endometrial pathology such as polyps and fibroids can be diagnosed and, if necessary, removed. A potential complication of endometrial resection is systemic fluid overload due to absorption of hysteroscopic fluid; therefore careful intraoperative input/output fluid balance requires attention and documentation. The efficacy and safety of first-generation techniques are often operator dependent. 

Newer technologies were subsequently introduced, including thermal balloon ablation, microwave ablation, free-fluid thermal ablation, radiofrequency ablation and cryotherapy. These ‘second-generation’ techniques have allowed widespread use of endometrial ablation, as they require less advanced hysteroscopic skill and do not necessitate intraoperative fluid balance. However, these procedures depend heavily on the surgical equipment itself for efficacy and safety. In some (but not all) instances, they can be performed without the hysteroscope altogether, making these approaches simpler, quicker and safer. 

How the intervention might work

Hysterectomy is regarded as ‘definitive’ treatment for HMB with guaranteed amenorrhoea and cessation of fertility and little need for future treatment. However, hysterectomy by any route is associated with all the complications of major surgery, including intraoperative bleeding, infection and venous thromboembolism. Other reported complications include urinary incontinence and dyspareunia. 

Although a successful outcome after endometrial ablation is not guaranteed and further surgery is occasionally required, many women still choose a less invasive surgical option (Nagele 1998; Bourdrez 2004). Endometrial resection/ablation is often chosen because of perceived short hospitalisation, quick return to normal functioning and avoidance of major surgery (Nagele 1998). Vaginal discharge and increased period pain are common complications following endometrial resection/ablation. Uncommon complications include intraoperative uterine perforation and associated pelvic organ injury from direct perforation or electrosurgical burns. 

Why it is important to do this review

HMB is a common reason for women to seek treatment, and many choose a surgical option as first- or second-line management. Surgical methods for treatment of HMB show a trend in favour of endometrial resection/ablation and towards newer endometrial resection/ablation techniques. In the late 1980s and early 1990s, 60% of women with HMB who were referred to a gynaecologist in the UK were treated with hysterectomy (Coulter 1991), but an examination of NHS statistics in 2005 revealed that endometrial destruction was being performed more frequently than hysterectomy for benign HMB in the UK (Reid 2007). 

Despite this trend, many women still express a preference for first-line hysterectomy (Kennedy 2002), and rates of different methods of hysterectomy are evolving.      

As surgical techniques for both hysterectomy and endometrial resection/ablation continue to evolve, corresponding changes in success rates, outcomes and complications will be noted, necessitating regular comparison and review. At the time of the 2008 review, robust evidence in the literature comparing less invasive hysterectomy techniques versus second-generation methods of endometrial ablation was lacking.

Objectives

The objective of this review is to compare the effectiveness, acceptability and safety of techniques of endometrial destruction by any means versus hysterectomy by any means for the treatment of heavy menstrual bleeding.

Methods

Criteria for considering studies for this review

Types of studies

Published and non-published randomised controlled trials (RCTs) were eligible for inclusion. Quasi-randomised trials were excluded.

Types of participants

Source of recruitment

Primary care, family planning and specialist clinics.

Inclusion criterion
  1. Women of reproductive years with heavy menstrual bleeding (including both heavy regular periods (menorrhagia) and heavy irregular periods (metrorrhagia)), measured objectively or subjectively.

Exclusion criteria
  1. Postmenopausal bleeding (> 1 year from the last period).

  2. HMB caused by uterine malignancy or endometrial hyperplasia.

  3. Iatrogenic causes of HMB (e.g. intrauterine coil devices).

Types of interventions

  1. Endometrial resection and ablation (including first-generation techniques, such as transcervical resection of the endometrium with loop electrode or rollerball, and second-generation techniques, such as endometrial ablation by thermal balloon, microwave, thermal free-fluid, radiofrequency and cryotherapy).

  2. Hysterectomy (by abdominal, vaginal and laparoscopic/laparoscopically assisted routes).

Types of outcome measures

Primary outcomes
Effectiveness (improvement in bleeding)

1.1 Woman's perception (proportion with improvement in bleeding symptoms).

1.2 PBAC (Pictorial Blood Loss Assessment Chart) score: a visual measure of amount of blood loss (clinically significant HMB correlates with a score > 100).*

1.3 Requirement for further surgery.

Acceptability

1.4 Proportion satisfied with treatment.

Safety (adverse outcomes)

1.5 Adverse events: short term (intraoperative and immediately postoperative).

1.6 Adverse events: long term (after hospital discharge).

Secondary outcomes

1.7 Quality of life scores (continuous data).

1.8 Quality of life (proportion with improvement).

1.9 Duration of surgery.

1.10 Duration of hospital stay.

1.11 Time to return to normal activity.

1.12 Time to return to work.

1.13 Total health service cost per woman.

1.14 Total individual cost per woman.

*PBAC score: A score over 100 suggests significantly heavy menstrual bleeding. A reduction from over 100 to under 100 would be clinically significant at an individual level.

Search methods for identification of studies

We searched all publications that would potentially describe RCTs comparing surgical techniques to resect or ablate the endometrium versus hysterectomy for the treatment of heavy menstrual bleeding. Search strategies for identifying potential studies for inclusion were employed in consultation with the Cochrane Menstrual Disorders and Subfertility Group Trials Search Co-ordinator.

Electronic searches

The original search was performed in 1999. Updated searches were performed in 2008 and 2013.

1. The principal and second review authors searched the trial register of the Menstrual Disorders and Subfertility Group using the search strategy developed by the Menstrual Disorders and Subfertility Group as follows:

Keywords CONTAINS "menorrhagia" or "heavy bleeding" or "heavy menstrual bleeding" or "heavy menstrual loss" or "dysfunctional uterine bleeding" or "dysfunctional bleeding" or Title CONTAINS "menorrhagia" or "heavy bleeding" or "heavy menstrual bleeding" or "heavy menstrual loss" or "dysfunctional uterine bleeding" or "dysfunctional bleeding".

AND

Keywords CONTAINS  "Hysterectomy" or "Hysterectomy, abdominal" or "hysterectomy, laparoscopically assisted vaginal" or "Hysterectomy, subtotal" or "Hysterectomy, Vaginal" or Title CONTAINS "Hysterectomy" or "Hysterectomy, abdominal" or "hysterectomy, laparoscopically assisted vaginal" or "Hysterectomy, subtotal" or "Hysterectomy, Vaginal". 

(See Review Group details for additional information.)

2. The two review authors then searched MEDLINE (1966 to October 2013; Appendix 1), EMBASE (1980 to October 2013; Appendix 2), PsycINFO (1972 to October 2013; Appendix 3) and the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library, Issue 10, 2013; Appendix 4), using the search strategy developed by The Cochrane Collaboration.

Searching other resources

  1. The principal review author searched all registers of the metaRegister of Controlled Trials in October 2013 to identify ongoing trials, trials that may have been missed by the search of electronic databases and trials that were unpublished.

  2. Citation lists of all studies that appeared to meet the inclusion criteria of the review, studies found in the literature review stage of the introduction, other relevant studies and evidence-based guidelines on the management of abnormal bleeding were also searched.

Data collection and analysis

Statistical analysis was performed in accordance with guidelines from the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). When possible, outcomes were pooled statistically.

Selection of studies

Trials for inclusion in the review were selected by two of the review authors (AL and IC or AL and SS in 2008, and RJF and AL in 2013) after the search strategy described previously was employed. This task was undertaken independently, and the final list of included studies reflected consensus between the two review authors. Details of the screening and selection process are shown in Figure 1.

Figure 1.

Study screening and selection process (2008 to 2013).

Data extraction and management

All assessments of characteristics of the included studies were performed independently by two review authors (AL and IC in 2008, and RJF and AL in 2013) using forms designed according to Cochrane guidelines and described in Higgins 2011

When necessary, additional information on trial methodology or original trial data were sought from the principal or corresponding author of any trials that appeared to meet the eligibility criteria (see Acknowledgements section for details of the study authors who provided clarification of data beyond that reported in the publications).

Quality criteria and methodological details were extracted from each study as follows.

Trial characteristics
  1. Study design.

  2. Numbers of women randomly assigned, excluded and lost to follow-up.

  3. Whether an intention-to-treat analysis was done.

  4. Whether a power calculation was done.

  5. Duration, timing and location of the study.

  6. Number of centres.

  7. Source of funding.

Characteristics of study participants
  1. Age and any other recorded characteristics of participants in the study.

  2. Other inclusion criteria.

  3. Exclusion criteria.

  4. Type of surgery.

  5. Source of participants.

  6. Proportion participating of those eligible.

Interventions used
  1. Type of endometrial destruction technique used and route of hysterectomy performed.

Outcomes
  1. Methods used to evaluate menstrual symptoms (e.g. PBAC score, woman-defined 'improvement in symptoms').

  2. Methods used to measure requirement for further surgery for HMB.

  3. Methods used to evaluate participant satisfaction and change in quality of life postsurgery.

  4. Methods used to record adverse surgical events.

  5. Methods used to measure resource and individual costs.

  6. Methods used to measure duration of surgery, hospital stay and recovery time.

Assessment of risk of bias in included studies

Included trials were assessed for risk of bias using the 'Risk of bias tool' developed by The Cochrane Collaboration and described in Higgins 2011.

  1. Sequence generation (whether the allocation sequence was adequately generated to produce comparable groups).

  2. Allocation concealment (whether the allocation was adequately concealed).

  3. Blinding of participants, personnel and outcome assessors (whether knowledge of the allocated intervention was adequately controlled during the study).

  4. Incomplete outcome data (whether incomplete outcome data were adequately addressed).

  5. Selective outcome reporting (whether reports of the study were free of the suggestion of selective outcome reporting).

  6. Other sources of bias (whether the study was apparently free of other problems that could put it at high risk of bias, e.g. baseline imbalance, bias related to study design, early termination of the study).

Details of the risk of bias for each included study are displayed in Characteristics of included studies and are summarised in Figure 2 and Figure 3.

Figure 2.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Figure 3.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Measures of treatment effect

For dichotomous data (e.g. number of adverse outcomes), we will use the numbers of events in the control and intervention groups of each study to calculate risk ratios (RRs). For continuous data (e.g. PBAC score), if all studies report exactly the same outcomes, we will calculate mean differences (MDs) between treatment groups. If similar outcomes are reported on different scales, we will calculate the standardised mean difference (SMD). We will reverse the direction of effect of individual studies, if required, to ensure consistency across trials. We will treat ordinal data (e.g. quality of life scores) as continuous data. We will present 95% confidence intervals for all outcomes. When data needed to calculate RRs or MDs are not available, we will utilise the most detailed numerical data available that may facilitate similar analyses of included studies (e.g. test statistics, P values). We will compare the magnitude and direction of effect reported by studies versus how they are presented in the review, while taking account of legitimate differences.

For dichotomous data (e.g. proportion of participants satisfied with their treatment), results of each study were expressed as a risk ratio. For some dichotomous outcomes (e.g. proportion of participants requiring further surgery), a higher proportion represented a negative consequence of that treatment, and for other outcomes (e.g. proportion with improvement in menstrual blood loss), a higher proportion was considered a benefit of treatment. This approach to the categorising of outcomes should be noted when summary graphs for the meta-analysis are viewed for assessment of benefits as opposed to harms of treatment. Thus, for some dichotomous outcomes, treatment benefit has been displayed as risk ratios and confidence intervals to the left of the centre line, but for others, a treatment benefit has been shown to the right of the centre line. Each outcome was labelled for clarification.

For other outcomes for which high values were considered a negative consequence of treatment, for example, duration of surgery, hospital stay and return to work, evaluation of the summary graphs reveals that means and confidence intervals to the left were considered a benefit of endometrial destruction.

With one exception, quality of life scores were entered as continuous data—mean plus standard deviation values post-treatment. One study, however, recorded the percentage mean change of Euroqol scores from baseline to four months after treatment. Some scales measured general quality of life summary score; others reported results separately in different categories, representing general quality of life but without a summary score; still others used more specific measurements of aspects of quality of life, such as anxiety, social adjustment and depression.

For some outcomes, women were assessed at different periods of follow-up after surgery.

  1. Menstrual symptoms were recorded at one, two, three and four years after surgery, PBAC scores at one and two years after surgery, and quality of life at four months and one, two and four years post-treatment.

  2. Adverse events were recorded before and after discharge from hospital.

  3. Requirement for further surgery was measured separately within the first year and at two, three and four years after treatment.

Unit of analysis issues

The unit of analysis was the woman with HMB who was randomly assigned to endometrial resection/ablation or to hysterectomy.

Dealing with missing data

Data were analysed on an intention-to-treat basis as far as possible; otherwise only available data were analysed. When data were found to be missing, attempts were made to obtain this information from the original trial authors.

Assessment of heterogeneity

Heterogeneity (variations) between the results of different studies was examined by visual inspection of scatter of data points on the graphs and overlap in their confidence intervals and, more formally, by examination of the results of the I2 quantity (a quantity that describes approximately the proportion of variation in point estimates that is due to heterogeneity rather than sampling error; Higgins 2008). When statistical heterogeneity was found to be very substantial (> 90%), calculation of a summary effect measure was not considered appropriate, and study data were not pooled. However, results of these studies can be viewed in forest plots that portray the range of values for comparison in each study.

Assessment of reporting biases

Avoidance of reporting bias was attempted by using a robust search strategy with no restrictions on language or publication forum. Multiple publications of the same study were identified for several of the included studies and are referenced as such. The use of funnel plots was planned to explore the possibility of small study effects if 10 or more studies had been included in the analysis.

Data synthesis

Combination of data was not always possible, as some outcomes were measured differently (e.g. some trials used PBAC score as a measure of improvement in bleeding, whilst others used proportion reporting improvement in bleeding symptoms, proportion with excessive bleeding, etc.). Such data were displayed in the forest plots; however, often only one trial contributed data to each plot.

For continuous data (e.g. PBAC score), if all studies reported exactly the same outcomes, mean differences (MDs) between treatment groups were calculated. Continuous outcomes were also displayed differently according to whether benefit or harm was measured. For most quality of life scores, a high score represented a benefit of treatment, but for the Hospital Anxiety and Depression Scale (HAD), a high score represented a greater degree of anxiety or depression. To display on the same graph quality of life scales that differed in this way, HAD scores were displayed as minus values, so that all quality of life continuous outcomes could be included in a single forest plot.

Subgroup analysis and investigation of heterogeneity

A priori, it was planned to explore the possible contribution of differences in trial design to any heterogeneity identified in the manner described above under 'Assessment of heterogeneity'. As a guide, I2 values ≤ 25%, = 50% and ≥ 75% correspond to low, moderate and high levels of heterogeneity (Higgins 2008).

Sensitivity analysis

To assess the robustness of pooled estimates, the following sensitivity analyses were conducted.

  1. Estimates whereby all types of hysterectomy were combined versus estimates for which each individual surgical approach was used.

  2. Estimates based on all relevant trials regardless of evidence of allocation concealment versus estimates based on trials that provided clear evidence that allocation was concealed.

The following analysis was planned but was not conducted.

  1. Estimates based on all relevant trials regardless of missing data and loss to follow-up versus estimates based on trials in which incomplete outcome assessment was not likely to cause bias.

Overall quality of the body of evidence: summary of findings table

Summary of findings for the main comparison was generated using GRADEPRO software. This table evaluates the overall quality of the body of evidence for the main review outcomes, using GRADE criteria.

  1. Study limitations (i.e. risk of bias).

  2. Consistency of effect.

  3. Imprecision.

  4. Indirectness.

  5. Publication bias.

Judgements about evidence quality (high, moderate, low or very low) were justified, documented and incorporated into reporting of results for each of these main outcomes.

Results

Description of studies

Eight RCTs comparing techniques of removal or ablation of endometrium versus hysterectomy by any route for the treatment of heavy menstrual bleeding were included. Two of these trials had multiple publications, each based on the same study population but providing assessment of different outcomes and different follow-up times, as well as cost-utility analyses of previously published data (Dwyer 1993; Pinion 1994). Trials comparing different types of endometrial destruction were not considered in this review but are assessed in Lethaby 2009. Details of included studies can be found in the Characteristics of included studies table.

Study design

All included studies used a parallel-group design. Six of these studies were carried out at a single centre (three in Italy, three in the UK), one study was performed at nine centres throughout the UK and one study was completed at 25 centres in the USA and Canada.

Participants

Participants in all included studies were premenopausal, had symptomatic heavy menstrual bleeding (regular or irregular prolonged or excessive bleeding) and were eligible for (i.e. had shown no response to medical treatment) or were awaiting hysterectomy. Participants in five of the included studies had received a diagnosis of menorrhagia (heavy regular bleeding), and participants in two of the studies had been given a diagnosis of dysfunctional uterine bleeding (which was defined as both regular and irregular ovulatory heavy bleeding and anovulatory abnormal bleeding not due to pathology). Exclusion criteria included large fibroids, large uterine size, pelvic inflammatory disease (PID) and endometriosis and abnormal pathology. Three studies excluded participants with submucosal fibroids.

Interventions

Available data mostly compared first-generation ablation techniques (predominantly transcervical resection of the endometrium (TCRE)) versus total hysterectomy. Two trials (Gannon 1991; Dwyer 1993) compared TCRE versus abdominal hysterectomy; the latter trial also included a preoperative procedure (medroxyprogesterone acetate injection four to six weeks before surgery) to reduce the thickness of the endometrium for participants undergoing endometrial resection. One trial compared endometrial resection versus vaginal hysterectomy (Crosignani 1997), another trial compared endometrial resection versus hysterectomy (50% abdominal, 50% vaginal) (O'Connor 1997) and another trial compared endometrial destruction after preoperative gonadotrophin-releasing hormone (GnRH) treatment (50% endometrial resection and 50% laser ablation) versus hysterectomy (88% abdominal and 12% vaginal) (Pinion 1994). One study compared endometrial resection or thermal balloon ablation (according to surgeon choice) versus total hysterectomy (vaginal, laparoscopic or abdominal approach, according to surgeon choice) (Dickerson 2007), another study compared endometrial resection after preoperative GnRH agonist (GnRHa) treatment versus laparoscopic supracervical hysterectomy (Zupi 2003) and the final study compared thermal balloon endometrial ablation versus laparoscopic supracervical hysterectomy (Sesti 2011).

Sensitivity analysis was undertaken to compare trial results with all types of hysterectomy included in the estimates versus exclusion of the more invasive types of hysterectomy to assess effects in the trials in which solely vaginal hysterectomy surgery or laparoscopic supracervical hysterectomy was performed (Crosignani 1997; Zupi 2003; Sesti 2011).

Outcomes

Follow-up after surgery for all included studies ranged from four months to four years. Six studies assessed change in menstrual bleeding patterns; four of these assessed whether menorrhagia-like symptoms had resolved (amount and frequency of bleeding), one study (in which participants had a complaint of dysfunctional bleeding) measured separate components of bleeding excess (excessive amount and duration) and another study used PBAC questionnaires. Four studies assessed time to return to normal activities in days. Two studies, in which participants had a diagnosis of dysfunctional bleeding, assessed whether an improvement in overall symptoms had occurred (recorded in one trial as 'problem solved'). Three studies measured costs of treatment.

All but three studies assessed satisfaction with surgery (although this was reported at different follow-up times) and return to work, all but two studies assessed postoperative complication rate and duration of surgery and all studies assessed hospital stay and requirement for further surgery.

Some outcomes measured time of surgery or recovery time and strictly speaking were time to event outcomes, such as duration of surgery, length of stay in hospital and time to return to normal activities and work. However, these were analysed as continuous data, as all participants had initial and end values representing the time that had elapsed. Time to event analysis is mandatory when censoring is performed and only a subset of participants have an event, but in this review, comparison of means was considered by the review authors to be an acceptable analysis.

Seven studies assessed quality of life after surgery, but several different scales were used. This review has assessed quality of life as measured by the Golombok Rust Inventory of Marital State (one year after surgery), the Short Form-36 Scale (SF-36), the Euroqol Visual Analogue Scale, the Hospital Anxiety and Depression Scale (HAD) and the Sabbatsberg Sexual Rating Scale (all one or two years after surgery). The SF-36 is a generic measure of subjective health in the form of a profile with eight multi-item dimensions (including physical and emotional role limitation, physical and social functioning, mental health, energy, pain and general health perception) developed in the USA and shown to be an acceptable tool when used by women with HMB (Ware 1993; Coulter 1994). The Euroqol health instrument is a generic single index measure of health-related quality of life validated in several European countries, including the UK (Euroqol Group 1990; Brazier 1993). The Golombok Rust Inventory was modified by the investigators to obtain a brief measure of the overall quality of the marital relationship (Rust 1986), and the Sabbatsberg Sexual Rating Scale was designed to provide a self assessment of sexual functioning by women engaging in intercourse (Garrat 1995). The Hospital Anxiety and Depression Scale is a self-assessment mood scale specifically designed to identify states of anxiety and depression and is regarded as a valid measure of the severity of these mood disorders (Zigmond 1983). Several other scales were used to evaluate aspects of quality of life in some of the trials, including the General Health Questionnaire, the Psychosocial Adjustment to Illness Scale, a psychiatric mood scale, a modified social adjustment scale and an unvalidated questionnaire, but these outcomes were not entered into the review because the data were not obtained in a suitable form for inclusion in a meta-analysis (quantitative data provided in graphical form indicated significant skew; data could not be obtained from study authors).

Five publications from three trials (Cameron 1996 and Aberdeen 1999 from the Pinion 1994 study; Gannon 1991; and Sculpher 1998 and Sculpher 1996 from the Dwyer 1993 study) compared costs to the health service of the two techniques. Two of these trials had two publications reporting total health resource costs of the procedures (including the need for retreatment) at different follow-up times (Cameron 1996 and Aberdeen 1999 (Pinion 1994); Sculpher 1993 and 1996 (Dwyer 1993)). One trial measured direct costs to the participant after one year (Cameron 1996 (Pinion 1994)).

Two trials (Sculpher 1993 and Sculpher 1996 from Dwyer 1993, and Cameron 1996 and Aberdeen 1999 from Pinion 1994) calculated cost per participant based on resource use. The third trial calculated costs by summing the average costs of variable resources and then adding a factor of 100% to allow for fixed costs (Gannon 1991).

Results of the search

The search was updated in October 2013 and included 62 additional potential references. Titles and abstracts were screened by two review authors (RJF and AL). Full-text copies of two references that appeared to meet the inclusion criteria were obtained; one was the re-publication of a trial already included in the 2008 review (Dickerson 2007), and the other was an additional new trial to be included (Sesti 2011), leading to a total of eight trials in the updated review.

Included studies

Eight RCTs of endometrial resection/ablation versus hysterectomy with a total of 1,260 randomly assigned participants met the criteria for inclusion in the review, although not all participants contributed to the assessment of every outcome.

Excluded studies

In the 2008 update of this review, two studies were retrieved for closer inspection and were excluded from the review (Paddison 2003; Lin 2006). One study had allocation according to date of admission and did not satisfy the criteria for true randomisation, and the other was a review of ablation versus hysterectomy.

No further studies were retrieved for closer inspection but subsequently excluded in the 2013 update of the review.

Risk of bias in included studies

All included studies were assessed separately for risk of bias (Higgins 2011). A summary of these assessments is provided in Figure 2 and Figure 3.

Allocation

Five of the eight included studies provided sufficient detail on the adequacy of the randomisation method (Crosignani 1997; O'Connor 1997; Zupi 2003; Dickerson 2007; Sesti 2011), all at low risk of bias. The other three studies did not describe how randomisation was undertaken and were therefore at unclear risk of bias in this category.

All but two studies (Gannon 1991; Zupi 2003) provided sufficient details of allocation concealment; these two studies were therefore at unclear risk of bias, and all other studies were at low risk of bias in this category.

Blinding

Three of the more recent studies used single blinding for assessment of some outcomes (Zupi 2003; Dickerson 2007; Sesti 2011). The other five studies did not appear to have any blinding of participants, investigators or assessors. All studies were therefore at high risk of bias in this category.

Incomplete outcome data

In two studies (O'Connor 1997; Dickerson 2007), withdrawal from the study and/or missing data were greater than 10%, and explanations were not provided to enable judgement of whether this could have biased the results. In the former trial, primary outcomes were analysed by an intention-to-treat method (satisfaction rate, quality of life and bleeding outcomes), but intraoperative and perioperative outcomes (adverse events, requirement for further surgery and hospital stay) were analysed according to surgery received. This trial also reported outcomes at three and four years' follow-up, but as women who were assigned later during the trial had shorter follow-up, these assessments are likely to be underpowered. The other six studies had withdrawals of less than 10% at the time of calculation of outcomes at the first time point. However, in studies with longer follow-up, additional loss to follow-up increased with the duration of the trial.

Selective reporting

Sufficient information was provided in only one study (Dickerson 2007) to indicate that it was free of selective outcome reporting. Before publication of the study results, an earlier publication provided details of the study protocol and changes made throughout the study (Dickerson 2007: other study cited under this ID). The other studies did not provide any evidence of measures taken to prevent selective outcome reporting.

Other potential sources of bias

In all of the studies, groups were balanced at baseline. In three studies (Gannon 1991; O'Connor 1997; Zupi 2003), the prior experience of the operating surgeon was described. However, this was not described in the remainder of the studies and could be a potential source of bias, as a less experienced surgeon for either treatment group could alter results such as duration of surgery, adverse outcomes and, in the case of endometrial ablation, effectiveness.

Effects of interventions

See: Summary of findings for the main comparison Endometrial resection/ablation for heavy menstrual bleeding

Endometrial resection and ablation versus hysterectomy

Primary outcomes
Effectiveness

A significant advantage favoured hysterectomy for improvement of bleeding outcomes. These were assessed in different ways in the trials, and not all outcomes could be pooled.

1.1 Woman's perception (proportion with improvement in bleeding symptoms)

Five trials assessed whether bleeding symptoms were perceived as improved; women randomly assigned to endometrial ablation were slightly less likely to show improvement in bleeding symptoms when compared with those randomly assigned to hysterectomy at one year (RR 0.89, 95% confidence interval (CI) 0.85 to 0.93, four studies, 650 women, I2 = 31%). Differences were also noted at later stages of follow-up, but these findings were only just within the range of statistical significance: at two years (RR 0.92, 95% CI 0.86 to 0.99, two studies, 292 women, I2 = 53%) and at four years (RR 0.93, 95% CI 0.88 to 0.99, two studies, 237 women, I2 = 79%; Figure 4; Analysis 1.1).

Figure 4.

Forest plot of comparison: 1 Endometrial resection/ablation versus hysterectomy, outcome: 1.1 Woman's perception (proportion with improvement in bleeding symptoms).

1.2 PBAC score

One trial assessed menstrual blood loss using the PBAC (Pictorial Blood Loss Assessment Chart) score. Compared with pretreatment scores, the PBAC score was significantly reduced in both groups at one and two years postoperatively; however, this finding overall significantly favoured women randomly assigned to hysterectomy at one year (MD 24.40, 95% CI 16.01 to 32.79, one study, 68 women), and even more so at two years (MD 44.00, 95% CI 36.09 to 51.91, one study, 68 women; Analysis 1.2).

1.3 Requirement for further surgery

Risk of repeat surgery for failure of the initial surgical treatment was significantly more likely for TCRE/ablation than for hysterectomy at all follow-up periods (all eight trials contributed data for at least one time point): within the first year (RR 14.9, 95% CI 5.2 to 42.6, six studies, 887 women, I2 = 0%), at two years (RR 23.4, 95% CI 8.3 to 65.8, six studies, 930 women, I2 = 0%), at three years (RR 11.1, 95% CI 1.5 to 80.1, one study, 172 women) and at four years (RR 36.4, 95% CI 5.1 to 259.2, one study, 197 women; Figure 5; Analysis 1.3).

Figure 5.

Forest plot of comparison: 1 Endometrial resection/ablation versus hysterectomy, outcome: 1.3 Proportion requiring further surgery for HMB.

Acceptability
1.4 Proportion satisfied with treatment

Satisfaction (very or moderately satisfied) rates were comparable (five trials) although lower amongst those who had endometrial ablation at two years after surgery (RR 0.87, 95% CI 0.80 to 0.95, four studies, 567 women, I2 = 0%).

No significant differences were noted between post-treatment satisfaction rates in groups at other follow-up times (one and four years), although the trend favoured hysterectomy (Figure 6; Analysis 1.4).

Figure 6.

Forest plot of comparison: 1 Endometrial resection/ablation versus hysterectomy, outcome: 1.4 Proportion satisfied with treatment.

Safety (adverse events)
1.5 Adverse events: short term (intraoperative and immediately postoperative)

Most short-term complications were more frequent after hysterectomy than after endometrial resection and ablation techniques. Women who had a hysterectomy were more likely to experience sepsis (RR 0.2, 95% CI 0.1 to 0.3, four studies, 621 women, I2 = 62%), blood transfusion (RR 0.2, 95% CI 0.1 to 0.6, four studies, 751 women, I2 = 0%), pyrexia (RR 0.2, 95% CI 0.1 to 0.4, three studies, 605 women, I2 = 66%), vault haematoma (RR 0.1, 95% CI 0.04 to 0.3, five studies, 858 women, I2 = 0%) and wound haematoma (RR 0.03, 95% CI 0.00 to 0.5, one study, 202 women) before their hospital discharge.

However, women who underwent TCRE/ablation were more likely to have fluid overload (RR 9.3, 95% CI 2.2 to 39.6, three studies, 611 women, I2 = 0%) when compared with those who had a hysterectomy.

No differences between groups were reported for haemorrhage, anaesthesia, perforation, gastrointestinal obstruction, laparotomy, cystotomy, cervical laceration, cardiorespiratory event, thromboembolic event or return to surgery as causes of postoperative complications, although some of these short-term results were based on the findings of only one study (Pinion 1994 or Dickerson 2007; Figure 7; Analysis 1.5).

Figure 7.

Forest plot of comparison: 1 Endometrial resection/ablation versus hysterectomy, outcome: 1.5 Adverse events—short term (intraoperative and immediate postoperative).

1.6 Adverse events: long term (after hospital discharge)

After hospital discharge, sepsis was more likely following hysterectomy in one study (RR 0.2, 95% CI 0.1 to 0.5, one study, 172 women), but no other significant differences were reported (Figure 8; Analysis 1.6).

Figure 8.

Forest plot of comparison: 1 Endometrial resection/ablation versus hysterectomy, outcome: 1.6 Adverse events—long term (after hospital discharge).

Secondary outcomes
Quality of life

Quality of life was measured by a number of validated scales. It was not possible to combine scales, as the domains differed, measuring different aspects of quality of life.

1.7 Quality of life scores (continuous data)

Significant differences were detected in five domains of the SF-36 Scale measured one and two years after surgery. Women randomly assigned to hysterectomy reported significantly higher scores on the social functioning (one and two years), pain (two years), energy (one year) and general health perception (one and two years) domains (social functioning: one year: MD -21.2, 95% CI -24.7 to -17.7, one study, 181 women; two years: MD -10.1, 95% CI -13.55 to -6.58, three studies, 300 women, I2 = 25%) (pain: two years: MD -9.5, 95% CI -12.8 to -6.2, four studies, 513 women, I2 = 63%) (energy: one year: MD -11.0, 95% CI -14.5 to -7.5, two studies, 211 women, I2 = 0%) (general health perception: one year: MD -7.3, 95% CI -10.7 to -3.8, two studies, 385 women, I2 = 81%; two years: MD -7.4, 95% CI -12.8 to -6.21, four studies, 509 women, I2 = 41%).

However, women randomly assigned to TCRE/ablation reported significantly higher scores for emotional role limitation at two years (MD 10.2, 95% CI 5.5 to 15.0, three studies, 300 women, I2 = 92%).

No statistically significant differences in SF-36 scores were noted between the two interventions in the domains of physical role limitation, mental health and physical functioning (Figure 9; Analysis 1.7).

Figure 9.

Forest plot of comparison: 1 Endometrial resection/ablation versus hysterectomy, outcome: 1.7 Quality of life scores (continuous data).

1.8 Quality of life (proportion with improvement)

Differences between groups were not reported in quality of life dimensions as measured by any of the other scales: Golombok Inventory, Euroqol Scale, Sabbatsberg Scale or HAD Scale. The dichotomous outcome of proportion with improvement in pain at two years was not significantly different between surgical groups. However, a greater proportion of those who had undergone a hysterectomy reported an improvement in their general health one year after surgery when compared with those who had received TCRE/ablation (RR 4.2, 95% CI 1.5 to 11.9, one study, 185 women). At four years, this difference between groups had narrowed and was just outside the level of significance (Analysis 1.8).

1.9 Duration of surgery

The duration of surgery was significantly longer for hysterectomy in all seven trials, especially when compared with laparoscopic hysterectomy. A pooled estimate was not included in this analysis, as a high degree of heterogeneity was noted, as discussed below under 'Heterogeneity' (Analysis 1.9).

1.10. Duration of hospital stay

Seven trials evaluated this outcome, and the results were significantly longer after hysterectomy in all trials. A pooled estimate was not included in this analysis, as a high degree of heterogeneity was noted, as discussed below under 'Heterogeneity' (Analysis 1.12).

1.11. Time to return to normal activity

Time to return to normal activity was significantly longer after hysterectomy in all four trials. A pooled estimate was not included in this analysis, as a high degree of heterogeneity was noted, as discussed below under 'Heterogeneity' (Analysis 1.11).

1.12. Time to return to work

Time to return to work was significantly longer after hysterectomy in four of the five trials (the fifth showed no significant difference). A pooled estimate was not included in this analysis, as a high degree of heterogeneity was noted, as discussed below under 'Heterogeneity' (Analysis 1.10).

1.13. Total health service cost per woman

All three trials evaluating costs reported that endometrial resection cost the health service less than hysterectomy for the management of heavy menstrual bleeding. This difference continued over a prolonged follow-up time, but the cost gap narrowed primarily because of the retreatment rate for women who underwent endometrial resection. By four years, ablation techniques cost between 5% and 11% less than a hysterectomy in one study that evaluated long-term follow-up (Aberdeen 1999 (Pinion 1994); Analysis 1.13).

1.14. Total individual cost per woman

One trial (Cameron 1996 (Pinion 1994)) measured costs to the women. At one year of follow-up, total personal costs, in terms of travel, loss of pay and child care, were higher for women who had a hysterectomy than for women who underwent endometrial ablation. However, women who had a hysterectomy estimated significantly greater savings in the cost of sanitary protection when compared with those who underwent endometrial ablation (savings of UK £85.10 per year vs UK £58.30 per year; Analysis 1.14).

Funnel Plots

Insufficient studies were included in the review for funnel plots to have sufficient power to distinguish chance from true asymmetry.

Heterogeneity

For some outcomes, a high level of heterogeneity was observed.

For many outcomes, only one trial contributed data, and analysis of heterogeneity was therefore not applicable. However, for four outcomes, data were contributed from several or all trials, and for these outcomes, the forest plots were visually inspected. The estimate for proportion requiring further surgery showed a low level of heterogeneity (all confidence intervals overlapping and I2 = 0% at one and two years of follow-up). However, a very high degree of heterogeneity was evident for outcomes such as duration of surgery (I2 = 99%), time to return to work (I2 = 100%) and time to return to normal activities (I2 = 97%).

The level of clinical heterogeneity for these outcomes may be explained in part by differences in interventions (most notably, mode of hysterectomy) throughout the trials. Two trials (Dwyer and Gannon) included abdominal hysterectomies only; one trial (Crosignani) included only vaginal hysterectomies; and two trials (Zupi and Sesti) included only laparoscopic hysterectomies. All other studies included two or all modes of hysterectomy. To investigate this further, a sensitivity analysis was conducted as below.

All trials had similar risk profiles for most measures in the risk of bias table. It is therefore assumed that no significant methodological heterogeneity was present.

Sensitivity Analysis

The first analysis was performed to determine whether mode of hysterectomy altered the estimates as compared with estimates when all types of hysterectomy were pooled. TCRE/ablation was compared individually against each mode of hysterectomy. 

For many of the outcomes, the estimates were largely unchanged when this analysis was conducted. Mode of hysterectomy did not change the estimates of comparisons for bleeding outcomes, requirement for further surgery, quality of life or satisfaction rates. In some instances, this occurred because only one trial contributed data to the particular outcome for the pooled estimate.

Mode of hysterectomy appeared to influence some aspects of surgical safety and several secondary outcomes. When laparoscopic hysterectomy was compared against TCRE/ablation, the risk ratios for the following short-term adverse outcomes were no longer statistically significant: blood transfusion (RR 0.20, 95% CI 0.07 to 0.59, to RR 0.21, 95% CI 0.01 to 4.27), pyrexia (RR 0.17, 95% CI 0.09 to 0.35, to RR 0.78, 95% CI 0.18 to 3.37) and vault haematoma (RR 0.11, 95% CI 0.04 to 0.34, to RR 0.21, 95% CI 0.01 to 4.25); however, the trend still favoured TCRE/ablation. 

All modes of hysterectomy were still associated with longer operating times, but this was most marked for laparoscopic hysterectomy, followed by vaginal hysterectomy, and least so for abdominal hysterectomy (mean difference (MD) for all modes pooled 39.6, 95% CI 55.1 to 24.1; for laparoscopic route comparison MD 75.3, 95% CI 165.4 to 14.8; for vaginal route comparison MD 57.6, 95% CI 60.3 to 54.9; and for abdominal route comparison MD 15.6, 95% CI 26.13 to 4.97). 

Mean differences in hospital stay remained significantly longer for both abdominal and vaginal hysterectomy when compared with TCRE/ablation (MD 4.9 days, 95% CI 6.5 to 3.2; MD 4.3 days, 95% CI 4.5 to 4.1, respectively), but the mean difference in hospital stay between TCRE/ablation and laparoscopic hysterectomy was only just statistically significant (MD 0.3 days, 95% CI 0.7 to 0.1). 

Abdominal hysterectomy was associated with the greatest difference in time to return to normal activities and time to return to work when compared with TCRE/ablation (MD 21 days, 95% CI 24.8 to 17.2; MD 8.2 weeks, 95% CI 9.5 to 6.8, respectively). For the same outcomes, when TCRE/ablation was compared against vaginal hysterectomy (MD 5 days, 95% CI 7.3 to 2.7; MD 2.4 weeks, 95% CI 2.7 to 2.1, respectively), the difference was less, particularly when compared against laparoscopic hysterectomy (MD 1.5 days, 95% CI 3.1 to 0.1; MD 0.04 weeks, 95% CI 0.3 to 0.25, respectively). 

A further analysis was performed to investigate the effect of clear evidence of allocation concealment on estimates. For six of the eight trials, clear evidence indicated that allocation was concealed, but for two trials (Gannon 1991 and Zupi 2003), this was not the case. When only trials with clear evidence of allocation concealment were included in the meta-analysis, no significant change was seen in the estimates compared with when all trials were included.

The following analysis was planned but was not conducted: estimates based on all relevant trials regardless of missing data and loss to follow-up versus estimates based on trials for which incomplete outcome assessment was not likely to cause bias. This analysis was not conducted, as no data were missing from the included trials.

Discussion

Summary of main results

This review assessed the benefits and harms of two surgical procedures for the treatment of heavy menstrual bleeding. When the primary outcomes of this review—effectiveness (woman's perception of improvement in bleeding outcomes, PBAC score, requirement for further surgery), acceptability and safety (adverse outcomes)—are considered, this review shows that both hysterectomy and TCRE/ablation are effective, acceptable and safe surgical treatments for heavy menstrual bleeding.

Whilst hysterectomy is more effective at reducing bleeding symptoms and improving quality of life and is associated with less repeated surgery than endometrial ablation, considerable short-term benefits are associated with endometrial ablation techniques when compared with hysterectomy, mainly in the areas of recovery time and cost.

Hysterectomy was completely successful in treating bleeding problems and led to very high levels (> 95% in most trials) of participant satisfaction up to two years after surgery. Satisfaction levels were also high for women who underwent endometrial ablation; they were significantly lower for these women when compared with hysterectomy at two years of follow-up, although the trend strongly favoured hysterectomy at earlier follow-up. Endometrial destruction techniques were also highly successful in reducing menstrual blood loss in most participants, but a proportion of participants (ranging from 3% to 18%) showed no improvement in their bleeding complaints. At most periods of follow-up, regardless of how bleeding symptoms were measured, women in the hysterectomy groups showed a significantly greater reduction in symptoms than those in the endometrial ablation groups. For some outcomes, it was suggested that these differences were no longer experienced at longer periods of follow-up, possibly because of reduced numbers and/or retreatment in the TCRE/ablation group.

Most quality of life measures were not markedly different between the two types of surgery, although evidence from analysis of SF-36 scores shows that women who had a hysterectomy perceived greater benefit for their general health, social functioning and energy levels at both one and two years and for pain levels at two years after surgery was completed compared with those having endometrial ablation. All other aspects of quality of life as measured by different instruments did not differ between groups.

Both surgical treatments were considered to be safe, with low complication rates reported. However, hysterectomy was associated with higher rates of sepsis, pyrexia, requirement for blood transfusion, vault haematoma and wound haematoma.

Duration of surgery, hospital stay, time to return to normal activities and time to return to work were shorter for those who had TCRE/ablation when compared with those who underwent hysterectomy. Although the findings from the included studies could not be pooled, almost all of the individual trials consistently reported a significant benefit for TCRE/ablation in these areas. Likely causes of heterogeneity for duration of surgery were variations in surgical route (e.g. vaginal vs abdominal vs laparoscopic hysterectomy or first-generation vs second-generation endometrial resection/ablation techniques), surgical technique and the expertise of surgeons carrying out the procedures.

Duration of hospital stay was likely to be affected by changes outside the control of investigators. Hospital policy for maximum stay can vary significantly between hospitals and could have accounted for the heterogeneity observed in the results for this outcome. Route of surgery (e.g. vaginal vs abdominal vs laparoscopic) partially explains the extreme heterogeneity in the time taken for recovery after discharge from hospital. Many hospitals worldwide are adopting a policy of 'enhanced recovery' following elective surgery, including shorter times to discharge for major operations such as abdominal hysterectomy. Future updates of this review may include trials that reflect this change.

Significant differences in operating time, hospital stay and time to return to normal activities and work can be seen in most of the trials, but the magnitude of these differences varies, depending on which mode of hysterectomy is being compared. Although precise estimates cannot be given, TCRE/ablation for abnormal bleeding takes less time to perform and has a shorter recovery time than hysterectomy. These differences are associated with a reduction in health service costs.

Evaluation of comparative costs between the two surgical procedures is affected by the increasing retreatment rate. Initially, treatment costs are much lower for women undergoing endometrial ablation than for those undergoing hysterectomy, but the difference in costs between the groups narrows over time because of the cost of retreatment. In one study with a minimum of four years of follow-up, endometrial ablation was reported to be only 5% to 11% less costly than hysterectomy compared with 24% and 29% less costly at one and two years of follow-up. Again here, 'enhanced recovery' policies may reflect a narrower difference in duration of hospital stay and therefore a corresponding narrower difference in patient costs.

As described previously, outcomes may be altered by the prior experience of the surgeon for both surgical procedures. A less experienced surgeon for either treatment group could alter results such as duration of surgery, adverse outcomes and, in the case of endometrial ablation, effectiveness.

Overall completeness and applicability of evidence

The included studies adequately addressed the review question: to assess the relative effectiveness, acceptability and safety of endometrial resection/ablation by any means and hysterectomy via any route for the treatment of heavy menstrual bleeding, as well as the secondary outcomes described above. The inclusion and exclusion criteria were largely met, and the interventions well described. Unfortunately, the outcomes (particularly measures of improvement in bleeding symptoms) were measured in several different ways, and it was not possible for all estimates to be pooled, making meta-analysis impossible for some outcomes.

On the whole, the review findings were consistent with currently accepted clinical advice and are in agreement with current guidelines. National Institute for Health and Care Excellence (NICE) guidelines for menorrhagia (NICE 2007) suggest that hysterectomy should not be used as a first-line treatment for benign HMB and should be considered only when other treatment options have failed, are contraindicated or are declined by the woman; when there is a wish for amenorrhoea; when the woman (who has been fully informed) requests it; and/or when the woman no longer wishes to retain her uterus and fertility. NICE 2007 guidelines are in agreement with the findings of this review with regard to potential complications associated with both modes of surgical treatment.

Quality of the evidence

In total, eight studies were included with a total of 1,260 randomly assigned participants.

All studies were at high risk of performance/detection bias, as it is not feasible to blind women or the surgeon against the type of operation that was performed. Several of the older studies were at high risk of selection bias.

As the studies used many different measurements for the outcomes (particularly for effectiveness of treatment), it was not possible to pool data for every outcome. However, the results were largely comparable; both treatments are considered to be effective and safe, hysterectomy was generally superior in improving symptoms and in leading to less requirement for future surgery and endometrial ablation was superior in terms of fewer adverse outcomes, shorter operating times and faster return to activities/work.

For many outcomes, assessment of heterogeneity was not relevant, as only one trial contributed data. For outcomes that displayed a high level of clinical heterogeneity, this was explained in part by differences in outcomes for different modes of hysterectomy (further described under 'Sensitivity analysis').

Quality of evidence was low to moderate, depending on the outcome. PBAC score, adverse events and proportion satisfied with treatment generated a moderate GRADE score, suggesting that further research may change the estimate. Outcomes that generated a low GRADE score included the woman’s perception of bleeding and the proportion of women requiring further surgery for HMB. For these two outcomes, further evidence is likely to change the estimate.

Potential biases in the review process

Electronic searches in combination with handsearches performed by the review authors identified all relevant studies known to be available currently. The inability to pool data for particular outcomes is likely to decrease the power of results; this may change if future studies are able to add data to the existing outcomes.

Agreements and disagreements with other studies or reviews

Bhattacharya 2011 performed a systematic review that compared clinical effectiveness and cost-effectiveness analyses of hysterectomy, endometrial ablation and Mirena for heavy menstrual bleeding. These findings were in accordance with the findings of this review; satisfaction rates at 12 months were highest for hysterectomy, and rates of further surgery after endometrial resection/ablation were comparable (8.5%). The authors also noted longer hospital stay and longer time to return to normal activities for hysterectomy.

Women who have undergone hysterectomy have experienced more postoperative complications than women who have received TCRE/ablation, although for some types of complications, no differences were reported. Because some complications are rare, these rates are best compared with those of large audits, such as the Mistletoe audit in the UK (Overton 1997). The low rate of complications for TCRE/ablation in this review confirms the findings of the Mistletoe study.

A comparison of costs of endometrial resection and ablation techniques versus those of hysterectomy cannot adequately provide information on the relative value in terms of money of these two surgical procedures. The availability of TCRE/ablation as a treatment for HMB may result in an earlier recourse to surgery than a woman would have considered if the only surgery available was hysterectomy (Bridgman 1994; Coulter 1994), and this will have a significant impact on costs. Additional studies have provided assessments of cost-effectiveness based on the Dwyer 1993 trial through a cost-utility analysis (Sculpher 1998), preference-based treatment allocation (woman allocated to the treatment that she prefers) (Sculpher 1998) and four other cost-utility analyses (Garside 2004; You 2006; Clegg 2007; Roberts 2011). Garside 2004 concluded that abdominal hysterectomy is likely to be more cost-effective than endometrial resection if healthcare purchasers are willing to pay an additional cost of at least UK £6,500 per extra quality-adjusted life-year (QALY) generated by hysterectomy, although an area of uncertainty is attached to this conclusion in the form of variation in the parameters used in the analysis. Clegg 2007 found that a preference-based treatment allocation was more cost-effective than reliance on a single intervention for all women requiring surgery for HMB. Garside 2004 reported that hysterectomy was more expensive than endometrial ablation but accrued more QALYs over 10 years. The incremental cost per QALY of hysterectomy compared with two second-generation endometrial ablation techniques was approximately UK £2,000. You 2006 also confirmed that hysterectomy was a more expensive option than endometrial ablation (cost per woman: US $6,878 vs US $6,185 over five years) but was more effective (4.725 QALYs vs 4.624 QALYs). Roberts 2011 found that hysterectomy produced more QALYs relative to second-generation endometrial ablation, with an incremental cost-effectiveness ratio of £970 per additional QALY. Data from the Clegg 2007 cost-utility analysis contradicted this finding; the authors reported that second-generation methods accrued marginally more QALYs than hysterectomy over five years (4.13 vs 4.01 QALYs). Evaluation of the comparative cost-effectiveness of endometrial destruction techniques and hysterectomy is complex, and the simple conclusion that endometrial destruction is cheaper than hysterectomy, with the difference narrowing over time, may not represent an adequate economic assessment.

Authors' conclusions

Implications for practice

  • Although hysterectomy is more effective at resolving bleeding problems and satisfaction rates are high, endometrial destruction by TCRE or ablation is an alternative to hysterectomy that should be offered to women with heavy menstrual bleeding.

  • TCRE/ablation techniques have satisfaction rates ranging from 70% to 80% with shorter operation time and hospital stay, earlier recovery and reduced postoperative complications. However, a preoperative discussion should focus on the possibility of further surgery being necessary for those women who choose endometrial destruction techniques for relief of their heavy menstrual bleeding.

  • The initial cost of endometrial destruction is significantly lower than that of hysterectomy, but because retreatment is often necessary, the cost difference narrows over time.

  • Laparoscopic hysterectomy represents an improvement of several of the previously described disadvantages of hysterectomy, and some outcomes such as duration of hospital stay, time to return to work and time to return to normal activities have become more comparable with those of endometrial ablation. It should be noted, however, that laparoscopic hysterectomy is associated with longer operating time than is required by other modes of hysterectomy and requires more sophisticated surgical expertise and equipment.

  • It is recommended that women be encouraged to play an active role in selecting the type of surgery, based on the personal value that they place on the advantages and disadvantages of each surgical approach.

Implications for research

Additional trials are needed in the following areas.

  • Comparison of more recent types of hysterectomy (supracervical, vaginal and laparoscopically assisted vaginal) versus endometrial ablation techniques. One further trial in this category was added in the 2013 update (Sesti 2011); however, more data are needed to reduce heterogeneity for some outcomes. Results from this trial did not contribute data to cost comparisons, and this is likely to be clinically important.

  • Comparison of second-generation ablation methods versus hysterectomy. Evidence suggests that whereas first-generation ablation methods did not have an impact on hysterectomy rates for HMB, second-generation methods have overtaken first-generation methods in the UK and are now the most common operation for HMB (Reid 2007). One further trial in this category was added in the 2013 update (Sesti 2011).

  • Trials with follow-up of four years or longer to adequately assess the cost differential between the two types of surgery and the requirement for further surgical treatment in women randomly assigned to TCRE or to endometrial ablation.

  • Trials that incorporate 'enhanced recovery' programmes. In the future, findings of these trials may reflect shorter hospital stay for women undergoing hysterectomy, and therefore a smaller difference between the two procedures for this particular outcome.

Acknowledgements

The review authors acknowledge the helpful comments of those who refereed previous versions of this review. We are especially grateful to Professor Pier Crosignani, Dr Kay Dickerson and Dr Sbracia, who answered queries and provided additional material for this review. Special thanks are also due to Helen Nagels, Managing Editor of the Menstrual Disorders and Subfertility Group, for her professionalism and help with the inevitable problems that arose, and to Marion Showell, Trials Search Co-ordinator, for her assistance in identifying trials.

The authors of the 2013 update acknowledge the contribution of Dr Inez Cooke, who wrote the protocol for the 2008 review.

Data and analyses

Download statistical data

Comparison 1. Endometrial resection/ablation versus hysterectomy
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Woman's perception (proportion with improvement in bleeding symptoms)5 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 Within one year of follow-up4650Risk Ratio (M-H, Fixed, 95% CI)0.89 [0.85, 0.93]
1.2 At two years of follow-up2292Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.86, 0.99]
1.3 At four years of follow-up2237Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.88, 0.99]
2 PBAC score (continuous data)1 Mean Difference (IV, Fixed, 95% CI)Subtotals only
2.1 At one year of follow-up168Mean Difference (IV, Fixed, 95% CI)24.4 [16.01, 32.79]
2.2 At two years of follow-up168Mean Difference (IV, Fixed, 95% CI)44.0 [36.09, 51.91]
3 Proportion requiring further surgery for HMB8 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 Within one year after surgery6887Risk Ratio (M-H, Fixed, 95% CI)14.94 [5.24, 42.57]
3.2 At two years after surgery6930Risk Ratio (M-H, Fixed, 95% CI)23.36 [8.30, 65.75]
3.3 At three years after surgery1172Risk Ratio (M-H, Fixed, 95% CI)11.10 [1.54, 80.14]
3.4 At four years after surgery1197Risk Ratio (M-H, Fixed, 95% CI)36.32 [5.09, 259.21]
4 Proportion satisfied with treatment5 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
4.1 At one year of follow-up4739Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.88, 1.00]
4.2 At two years of follow-up4567Risk Ratio (M-H, Fixed, 95% CI)0.87 [0.80, 0.95]
4.3 At four years of follow-up2246Risk Ratio (M-H, Fixed, 95% CI)0.89 [0.77, 1.03]
5 Adverse events—short term (intraoperative and immediate postoperative)6 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
5.1 Sepsis4621Risk Ratio (M-H, Fixed, 95% CI)0.19 [0.12, 0.31]
5.2 Haemorrhage3555Risk Ratio (M-H, Fixed, 95% CI)0.69 [0.32, 1.46]
5.3 Blood transfusion4751Risk Ratio (M-H, Fixed, 95% CI)0.20 [0.07, 0.59]
5.4 Pyrexia3605Risk Ratio (M-H, Fixed, 95% CI)0.17 [0.09, 0.35]
5.5 Vault haematoma5858Risk Ratio (M-H, Fixed, 95% CI)0.11 [0.04, 0.34]
5.6 Wound haematoma1202Risk Ratio (M-H, Fixed, 95% CI)0.03 [0.00, 0.53]
5.7 Anaesthetic1202Risk Ratio (M-H, Fixed, 95% CI)0.18 [0.01, 3.80]
5.8 Fluid overload3611Risk Ratio (M-H, Fixed, 95% CI)9.27 [2.17, 39.64]
5.9 Perforation2430Risk Ratio (M-H, Fixed, 95% CI)5.05 [0.61, 42.16]
5.10 Gastrointestinal obstruction/ileus1202Risk Ratio (M-H, Fixed, 95% CI)0.46 [0.04, 5.01]
5.11 Laparotomy2383Risk Ratio (M-H, Fixed, 95% CI)0.39 [0.08, 1.97]
5.12 Cystotomy1228Risk Ratio (M-H, Fixed, 95% CI)0.21 [0.01, 4.42]
5.13 Cervical laceration2409Risk Ratio (M-H, Fixed, 95% CI)3.16 [0.33, 30.10]
5.14 Cardiorespiratory event1228Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.01, 2.93]
5.15 Thromboembolic event1228Risk Ratio (M-H, Fixed, 95% CI)0.21 [0.01, 4.42]
5.16 Readmission/return to surgery1228Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.01, 2.93]
6 Adverse events—long term (after hospital discharge)2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
6.1 Sepsis1172Risk Ratio (M-H, Fixed, 95% CI)0.27 [0.13, 0.58]
6.2 Haematoma2368Risk Ratio (M-H, Fixed, 95% CI)0.59 [0.15, 2.37]
6.3 Haemorrhage1196Risk Ratio (M-H, Fixed, 95% CI)2.94 [0.12, 71.30]
7 Quality of life scores (continuous data)6 Mean Difference (IV, Fixed, 95% CI)Subtotals only
7.1 SF-36 at one year—Role Limitation (physical)1181Mean Difference (IV, Fixed, 95% CI)-0.80 [-4.99, 3.39]
7.2 SF-36 at one year—Role Limitation (emotional)1181Mean Difference (IV, Fixed, 95% CI)-3.90 [-8.21, 0.41]
7.3 SF-36 at one year—Social Functioning1181Mean Difference (IV, Fixed, 95% CI)-21.20 [-24.73, -17.67]
7.4 SF-36 at one year—Mental Health2385Mean Difference (IV, Fixed, 95% CI)-1.53 [-5.06, 2.01]
7.5 SF-36 at one year—Energy2211Mean Difference (IV, Fixed, 95% CI)-10.99 [-14.45, -7.53]
7.6 SF-36 at one year—Pain2391Mean Difference (IV, Fixed, 95% CI)-1.91 [-5.67, 1.86]
7.7 SF-36 at one year—General Health Perception2385Mean Difference (IV, Fixed, 95% CI)-7.27 [-10.72, -3.81]
7.8 SF-36 at one year—Physical Functioning1181Mean Difference (IV, Fixed, 95% CI)-1.20 [-5.34, 2.94]
7.9 SF-36 at two years—Role Limitation (physical)3300Mean Difference (IV, Fixed, 95% CI)-3.09 [-7.94, 1.76]
7.10 SF-36 at two years—Role Limitation (emotional)3300Mean Difference (IV, Fixed, 95% CI)10.22 [5.48, 14.96]
7.11 SF-36 at two years—Social Functioning3300Mean Difference (IV, Fixed, 95% CI)-10.06 [-13.55, -6.58]
7.12 SF-36 at two years—Mental Health4509Mean Difference (IV, Fixed, 95% CI)2.39 [-0.61, 5.40]
7.13 SF-36 at two years—Energy4513Mean Difference (IV, Fixed, 95% CI)-2.01 [-5.41, 1.40]
7.14 SF-36 at two years—Pain4513Mean Difference (IV, Fixed, 95% CI)-9.50 [-12.80, -6.21]
7.15 SF-36 at two years—General Health Perception4509Mean Difference (IV, Fixed, 95% CI)-7.42 [-10.64, -4.20]
7.16 SF-36 at two years—Physical Functioning3300Mean Difference (IV, Fixed, 95% CI)-9.29 [-12.80, -5.78]
7.17 GR inventory scores at one year after surgery1182Mean Difference (IV, Fixed, 95% CI)0.0 [-1.75, 1.75]
7.18 Euroqol score within one year after surgery2347Mean Difference (IV, Fixed, 95% CI)-3.24 [-8.35, 1.88]
7.19 Euroqol scores at two years after surgery2368Mean Difference (IV, Fixed, 95% CI)-1.96 [-5.60, 1.67]
7.20 SSR score at two years after surgery177Mean Difference (IV, Fixed, 95% CI)-3.70 [-11.17, 3.77]
7.21 Total HAD scores at two years after surgery177Mean Difference (IV, Fixed, 95% CI)-1.5 [-4.32, 1.32]
7.22 Anxiety HAD scores at two and four years after surgery2259Mean Difference (IV, Fixed, 95% CI)-0.67 [-1.64, 0.30]
7.23 Depression HAD scores at two and four years after surgery2259Mean Difference (IV, Fixed, 95% CI)-0.00 [-0.10, 0.09]
8 Quality of life (proportion with improvement)2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
8.1 Proportion with improvement in pain two years after surgery159Risk Ratio (M-H, Fixed, 95% CI)1.60 [0.55, 4.63]
8.2 Proportion with improvement in general health one year after surgery1185Risk Ratio (M-H, Fixed, 95% CI)4.17 [1.47, 11.85]
8.3 Proportion with improvement in general health four years after surgery1146Risk Ratio (M-H, Fixed, 95% CI)2.76 [0.93, 8.17]
9 Duration of surgery (minutes)7 Mean Difference (IV, Random, 95% CI)Totals not selected
10 Time to return to work (weeks)5 Mean Difference (IV, Random, 95% CI)Totals not selected
11 Time to return to normal activity (days)4 Mean Difference (IV, Random, 95% CI)Totals not selected
12 Duration of hospital stay (days)7 Mean Difference (IV, Random, 95% CI)Totals not selected
13 Total health service cost per woman  Other dataNo numeric data
14 Total individual cost per woman  Other dataNo numeric data
Analysis 1.1.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 1 Woman's perception (proportion with improvement in bleeding symptoms).

Analysis 1.2.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 2 PBAC score (continuous data).

Analysis 1.3.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 3 Proportion requiring further surgery for HMB.

Analysis 1.4.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 4 Proportion satisfied with treatment.

Analysis 1.5.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 5 Adverse events—short term (intraoperative and immediate postoperative).

Analysis 1.6.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 6 Adverse events—long term (after hospital discharge).

Analysis 1.7.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 7 Quality of life scores (continuous data).

Analysis 1.8.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 8 Quality of life (proportion with improvement).

Analysis 1.9.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 9 Duration of surgery (minutes).

Analysis 1.10.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 10 Time to return to work (weeks).

Analysis 1.11.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 11 Time to return to normal activity (days).

Analysis 1.12.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 12 Duration of hospital stay (days).

Analysis 1.13.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 13 Total health service cost per woman.

Total health service cost per woman
Study 
Dwyer 1993

FOUR MONTHS FOLLOW UP
Mean resource cost per patient (UK pounds) in 1991/92 prices:
Endometrial resection: UK pounds 560.05 (SD 261.22)
Hysterectomy: UK pounds 1059.73 (SD 198.04)
These costs were made up of pre-operative, operative and post-operative costs, hotel costs, complications costs, re-treatment and general practice costs.
Mean difference in cost between groups : UK pounds -499.68 (95% CI -567 to -432)
Statistical test not specifically stated.
Mean cost of resection at 4 months follow up 53% the cost of hysterectomy.

2.2 YEARS OF FOLLOW UP
Mean resource cost per patient (UK pounds) in 1994 prices:
Endometrial resection: UK pounds 790 (SD 493)
Hysterectomy: UK pounds 1110 (SD 168)
Costs made up of initial surgery, re-treatment costs, other resource use after 4 months and HRT.
Wilcoxon Rank Sum test used to test the difference between groups with a 5% significance level, p=0.0001.
Mean cost of resection at 2.2 years of follow up 71% the cost of hysterectomy.

Gannon 1991INITIAL COSTS (NHS)
Mean cost per operation (UK pounds) in 1991:
Endometrial resection: UK pounds 407 Abdominal hysterectomy: UK pounds 1270
This cost was made up of: (1) variable costs: average cost of theatre consumables, staffing and maintenance in the operating theatre, marginal cost of a bed on the gynaecological ward; and (2) fixed costs: capital depreciation, hospital staffing and energy.
The difference between groups in resource cost was not assessed in a statistical test.
Pinion 1994

ONE YEAR OF FOLLOW UP
Mean resource cost per patient in UK pounds in 1994:
Endometrial resection: UK pounds 1001.00
Laser ablation: UK pounds 1046.00
Hysterectomy: UK pounds 1315.00
No statistical test used to compare the difference between groups.
Mean cost of endometrial resection at 1 year of follow up 76% of cost of hysterectomy.
Mean cost of laser ablation at 1 year of follow up 80% of cost of hysterectomy.
Costs based on pre-operative costs, nights in hospital, theatre and ward costs, GP and out-patient costs, re-treatment costs and technical equipment costs.

FOUR YEARS OF FOLLOW UP
Mean resource cost per patient in UK pounds in 1994:
Endometrial destruction techniques: UK pounds 1231
Hysterectomy: UK pounds 1332
Includes additional costs for re-treatment or additional procedures arising between 1 and 4 years after surgery. Data reported as 1994 rates (discounted by 6%).
Sensitivity analysis performed with variations in the discount rate.
Cost of endometrial ablation techniques at 4 years reported as between 89% and 95% the costs of hysterectomy.

Analysis 1.14.

Comparison 1 Endometrial resection/ablation versus hysterectomy, Outcome 14 Total individual cost per woman.

Total individual cost per woman
Study 
Pinion 1994

ONE YEAR OF FOLLOW UP
Mean patient cost in UK pounds in 1994 prices:
Hysteroscopic surgery: UK pounds 21.00 (95% CI 13.3, 33.1)
Hysterectomy: UK pounds 73.40 (95% CI 42.1, 127)
Mean cost of hysteroscopic surgery 29% the cost of hysterectomy surgery.
Costs estimated included loss of pay, child care and travel expenses.
Student t test used to compare differences between surgery groups, p<0.05.

Mean annual savings from sanitary protection after treatment in UK pounds in 1994:
Hysteroscopic surgery: UK pounds 58.30 (95% CI 51.4, 66)
Hysterectomy: UK pounds 85.10 (95% CI 72.2, 100)
Student t test used to compare differences between surgery groups, p<0.05.

Appendices

Appendix 1. MEDLINE search strategy

MEDLINE (Oct 2013)

1 menorrhagia/ (3183)

2 menorrhag$.tw. (2395)

3 (menstrua$ adj5 (bleed$ or blood)).tw. (3013)

4 (heavy adj5 menstrua$).tw. (382)

5 (dysfunctional adj5 uter$).tw. (875)

6 hypermenorrh$.tw. (227)

7 or/1-6 (7373)

8 exp hysterectomy/ or hysterectomy, vaginal/ (22260)

9 hysterectom$.tw. (23155)

10 (uter$ adj5 excis$).tw. (312)

11 or/8-10 (33138)

12 7 and 11 (1298)

13 exp Electrocoagulation/ (26485)

14 exp Endometrium/su [Surgery] (956)

15 Laser Coagulation/ (5566)

16 (endometri$ adj5 (ablat$ or excis$ or laser or electrocautery or destruct$ or radiofrequency)).tw. (1676)

17 (endometri$ adj5 resect$).tw. (891)

18 (electrosurgery or thermal balloon or hypertherm$ or thermotherapy or photodynamic therapy or phototherapy or cryoablation or microwave ablation).tw. (42180)

19 (Thermachoice or rollerball).tw. (160)

20 or/13-19 (74778)

21 12 and 20 (524)

22 randomized controlled trial.pt. (318052)

23 controlled clinical trial.pt. (83363)

24 randomized.ab. (233818)

25 placebo.tw. (135936)

26 clinical trials as topic.sh. (157231)

27 randomly.ab. (172164)

28 trial.ti. (100048)

29 (crossover or cross-over or cross over).tw. (52002)

30 or/22-29 (779192)

31 exp animals/ not humans.sh. (3644792)

32 30 not 31 (719339)

33 21 and 32 (78)

34 200812$.ed. (60258)

35 (2009$ or 2010$ or 2011$ or 2012$).ed. (2752229)

36 34 or 35 (2812487)

37 33 and 36 (9)

Appendix 2. EMBASE search strategy

Embase (Oct 2013)

1 menorrhagia/ (4895)

2 menorrhag$.tw. (2876)

3 (menstrua$ adj5 (bleed$ or blood)).tw. (3119)

4 (heavy adj5 menstrua$).tw. (467)

5 (dysfunctional adj5 uter$).tw. (994)

6 hypermenorrh$.tw. (246)

7 or/1-6 (8807)

8 exp hysterectomy/ or hysterectomy, vaginal/ (37207)

9 hysterectom$.tw. (27732)

10 (uter$ adj5 excis$).tw. (345)

11 or/8-10 (43924)

12 7 and 11 (2038)

13 electrosurgery/ or exp electrocoagulation/ or laser surgery/ (33638)

14 exp laser coagulation/ (16943)

15 endometrium ablation/ (1426)

16 (endometri$ adj5 (ablat$ or excis$ or laser or electrocautery or destruct$ or radiofrequency)).tw. (2265)

17 (endometri$ adj5 resect$).tw. (1209)

18 (electrosurgery or thermal balloon or hypertherm$ or thermotherapy or photodynamic therapy or phototherapy or cryoablation or microwave ablation).tw. (48902)

19 (Thermachoice or rollerball).tw. (215)

20 or/13-19 (97144)

21 12 and 20 (749)

22 Clinical Trial/ (823391)

23 Randomized Controlled Trial/ (296049)

24 exp randomization/ (55545)

25 Single Blind Procedure/ (14708)

26 Double Blind Procedure/ (102662)

27 Crossover Procedure/ (31692)

28 Placebo/ (191316)

29 Randomi?ed controlled trial$.tw. (68133)

30 Rct.tw. (8386)

31 random allocation.tw. (1084)

32 randomly allocated.tw. (16117)

33 allocated randomly.tw. (1727)

34 (allocated adj2 random).tw. (691)

35 Single blind$.tw. (11443)

36 Double blind$.tw. (120767)

37 ((treble or triple) adj blind$).tw. (256)

38 placebo$.tw. (164221)

39 prospective study/ (180838)

40 or/22-39 (1170162)

41 case study/ (14485)

42 case report.tw. (212909)

43 abstract report/ or letter/ (805490)

44 or/41-43 (1028696)

45 40 not 44 (1136367)

46 21 and 45 (206)

47 (2010$ or 2011$ or 2012$).em. (2563197)

48 46 and 47 (33)

Appendix 3. PsycINFO search strategy

1 exp menstrual disorders/ (911)

2 menorrhag$.tw. (65)

3 (menstrua$ adj5 (bleed$ or blood)).tw. (170)

4 (heavy adj5 menstrua$).tw. (15)

5 (dysfunctional adj5 uter$).tw. (17)

6 hypermenorrh$.tw. (2)

7 or/1-6 (1114)

8 exp Hysterectomy/ (354)

9 hysterectom$.tw. (618)

10 (uter$ adj5 excis$).tw. (2)

11 or/8-10 (640)

12 7 and 11 (29)

Appendix 4. CENTRAL search strategy

CENTRAL (Oct 2013)

1 menorrhagia/ (216)

2 menorrhag$.tw. (296)

3 (menstrua$ adj5 (bleed$ or blood)).tw. (370)

4 (heavy adj5 menstrua$).tw. (51)

5 (dysfunctional adj5 uter$).tw. (96)

6 hypermenorrh$.tw. (13)

7 or/1-6 (707)

8 exp hysterectomy/ or hysterectomy, vaginal/ (1336)

9 hysterectom$.tw. (2081)

10 (uter$ adj5 excis$).tw. (6)

11 or/8-10 (2303)

12 7 and 11 (117)

13 exp Electrocoagulation/ (1134)

14 exp Endometrium/su [Surgery] (94)

15 Laser Coagulation/ (338)

16 (endometri$ adj5 (ablat$ or excis$ or laser or electrocautery or destruct$ or radiofrequency)).tw. (231)

17 (endometri$ adj5 resect$).tw. (129)

18 (electrosurgery or thermal balloon or hypertherm$ or thermotherapy or photodynamic therapy or phototherapy or cryoablation or microwave ablation).tw. (2066)

19 (Thermachoice or rollerball).tw. (42)

20 or/13-19 (3712)

21 12 and 20 (63)

22 limit 21 to yr="2008 -Current" (11)

Appendix 5. Additional searches

CINAHL, Google, Google Scholar and PubMed were searched using the key words ‘endometrial ablation’, ‘endometrial resesction’, ‘hysterectomy’, ‘heavy menstrual bleeding’, ‘menorrhagia’, ‘disordered uterine bleeding’ and ‘abnormal uterine bleeding’.

What's new

DateEventDescription
1 November 2013New citation required but conclusions have not changedOne new study added: Sesti 2011.
1 November 2013New search has been performedOne new study added: Sesti 2011.

History

Protocol first published: Issue 3, 1996
Review first published: Issue 2, 1999

DateEventDescription
15 January 1999New citation required and conclusions have changedSubstantive amendment

Contributions of authors

In the 2013 version of the review, Dr Rosalie Fergusson rewrote all sections of the review, including updating the protocol in line with current Cochrane Collaboration standards.

Dr Rosalie Fergusson and Anne Lethaby performed searches for relevant studies, selected studies for inclusion based on the protocol criteria, assessed the included trials for quality and performed data extraction and entered data, aside from the sections involving cost, for the 2013 update. They also incorporated changes suggested by the peer review.

In the 2008 version of the review, Dr Sasha Shepperd was involved in selection of trials for inclusion and independently assessed the quality of the included studies and performed data extraction. She performed a significant role in editing the final draft and analysing the cost data. Dr Cindy Farquhar wrote the conclusions to the first published version of the review and helped edit the final draft when the review was first published.

Declarations of interest

No conflicts of interest were reported.

Sources of support

Internal sources

  • Department of Obstetrics and Gynaecology, National Women's Hospital, Auckland, New Zealand.

External sources

  • NHS Executive, Anglia and Oxford Region R&D Programme, UK.

  • Health Research Council, Auckland, New Zealand.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Crosignani 1997

MethodsRandomisation by computer-generated sequence using numbered opaque sealed envelopes
Single-centre, parallel-group with no blinding
Number of women randomly assigned: n = 92
Number of withdrawals: n = 7 (four in the resection group: one refused treatment, one underwent surgery in another hospital, one did not want further treatments, and one was lost to follow-up before surgery; three in the hysterectomy group: one refused treatment, one had surgery in another hospital and one decided on long-term medical treatment)
Power calculation for sample size performed and analysis by intention to treat
Source of funding not reported
ParticipantsWomen 42 to 49 years of age, with menorrhagia not responding to medical treatment and requiring hysterectomy, recruited from an outpatient clinic in Milan, Italy
Inclusion criteria: ≤ 50 years, mobile uterus with volume < 12 weeks in gestational size and < 380 mL on ultrasound, negative cervical smear, no evidence of atypical hyperplasia at endometrial biopsy, no adnexal tumours at clinical and ultrasound examination
Exclusion criteria: known PID or endometriosis, urinary stress incontinence, moderate/severe genital prolapse, clotting disorders, use of IUD or drugs that may affect MBL, unstable general conditions, submucous myomas > 3 cm in diameter or > 50% intramural extension
Interventions

Rx 1: hysteroscopic endometrial resection
Rx 2: vaginal hysterectomy
Duration: two years of follow-up

Prior experience of the surgeon not mentioned

OutcomesParticipant satisfaction with treatment
Improvement in MBL
Quality of life
Duration of surgery (minutes)
Duration of hospital stay (days)
Return to work (weeks)
Requirement for further surgery
NotesAuthor contacted for additional information and reply received
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated randomisation sequence
Allocation concealment (selection bias)Low riskNumbered opaque sealed envelopes
Blinding (performance bias and detection bias)
All outcomes
High riskNot feasible for a comparison of surgical techniques
Incomplete outcome data (attrition bias)
All outcomes
Low riskClear reasons given for withdrawal—appeared balanced in numbers between groups
Selective reporting (reporting bias)Unclear riskUnclear—no protocol identified. Study did not measure adverse events
Other biasLow riskGroups appeared balanced at baseline (although the table did not include dropouts), and no other biases were identified

Dickerson 2007

Methods

Randomisation by computer-generated permuted blocks of random size stratified by age and site

Multi-centre (n = 25), parallel-group, single-blinded (only assessors)

Number of women randomly assigned: n = 237

Number of withdrawals: at one year: 16 in endometrial ablation group, 11 in hysterectomy group; at two years: 17 in endometrial ablation group, seven in hysterectomy group

Power calculation for sample size (90% power based on quality of life measures) but recruitment did not quite achieve the required sample size

Analysis was by intention to treat for primary bleeding and satisfaction outcomes. Analysis was not by intention to treat for assessment of intraoperative and perioperative events

Source of funding: AHRQ and Brown Medical School

ParticipantsWomen with dysfunctional bleeding (not explained by pathology, drugs, etc.), most of whom were younger than 45 years of age (85%), recruited from 25 clinical centres in United States and Canada. Inclusion: 18 years of age or older; premenopausal; dysfunctional uterine bleeding for at least six months (defined as one or more of excess duration, amount or unpredictability); refractory to medical treatment for at least three months. Exclusion: postmenopausal; bilateral oophorectomy; pregnant; wishing to retain fertility; refusal to consider surgery
Interventions

Rx 1: resectoscopic endometrial ablation with electrodesiccation/coagulation or vaporisation OR ablation with thermal balloon

Rx 2: vaginal, laparoscopic or abdominal hysterectomy under general or regional anaesthesia. In both groups, women > 45 years were allowed oophorectomy

Duration of trial: enrolment was staggered, with some women having data for five years

Prior experience of the surgeon not mentioned

Outcomes

Pain, bleeding and fatigue at one year

Other outcomes at different time points: QOL outcomes, sexual function, employment, housework, leisure activities, out-of-pocket costs, health provider visits, surgical complications, additional surgery

NotesAuthor contacted for clarification of some points and reply received
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandomisation schedule (computer-generated permuted blocks) was developed by the Co-ordinating Centre and was stratified by participating centre
Allocation concealment (selection bias)Low riskCentral allocation
Blinding (performance bias and detection bias)
All outcomes
High riskSingle blinding for interviewers requesting information on bleeding history, quality of life, etc. But women providing this information knew of their assignment
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo reasons given for dropouts
Selective reporting (reporting bias)Low riskProtocol published with details on prespecified outcomes
Other biasLow riskGroups appear balanced at baseline. However, some outcomes (intraoperative and perioperative events, including adverse events) reported according to surgery received

Dwyer 1993

MethodsRandomisation by sealed numbered envelopes in variable blocks of 20, 30 and 50
Single-centre, parallel-group, no blinding
Number of women randomly assigned: n = 200
Number of withdrawals: n = 4 (three from the hysterectomy group and one from the resection group)
Power calculation for sample size performed but intention-to-treat analysis not reported
Source of funding: South West Regional Health Authority
ParticipantsWomen with mean age of 40 years, recruited from an outpatient gynaecology clinic at a teaching hospital in Bristol, UK
Inclusion criteria: < 52 years of age, complaint of menorrhagia that could not be controlled by conservative means, candidates for abdominal hysterectomy
Exclusion criteria: uterine size ≤ 12 gestational weeks, additional symptoms or other pathology, making hysterectomy the preferred treatment
Interventions

Rx 1: endometrial resection, n = 99
Rx 2: abdominal hysterectomy, n = 97
Duration: four months of follow-up, 2.8 years of follow-up

Prior experience of the surgeon not mentioned

OutcomesSatisfaction with surgery at four months
Satisfaction with surgery at 2.8 years
Change in menstrual blood loss after surgery (subjective) at four months
Change in menstrual blood loss after surgery (subjective) at 2.8 years
Quality of life at 2.8 years
Postoperative complications
Duration of hospital stay (days)
Duration of surgery (minutes)
Return to work (weeks)
Requirement for further surgery within one year
Requirement for further surgery at 2.8 years
Total health service resource cost at four months
Total health service resource cost at 2.8 years
NotesThree publications used the same study population: Dwyer 1993; Sculpher 1993; Sculpher 1996
Dr Dwyer contacted for additional information but no reply received
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomisation sequence not described
Allocation concealment (selection bias)Low riskSealed numbered envelopes in variable blocks
Blinding (performance bias and detection bias)
All outcomes
High riskNot feasible for a comparison of surgical techniques
Incomplete outcome data (attrition bias)
All outcomes
Low riskDropouts from trial minimal and not likely to bias results
Selective reporting (reporting bias)Unclear riskNo prior protocol identified
Other biasLow riskGroups appeared balanced at baseline. No other bias identified

Gannon 1991

MethodsRandomisation by sealed envelope
Single-centre, parallel-group, no blinding
Number of women randomly assigned: n = 54
Number of withdrawals: n = 3 (one from the resection group who wanted hysterectomy, one from the hysterectomy group who wanted resection and one from the hysterectomy group who postponed surgery and was treated elsewhere)
Power calculation and intention-to-treat analysis not reported
Source of funding: not reported
ParticipantsWomen with median age 40 years and awaiting abdominal hysterectomy for menorrhagia, recruited from the Royal Berkshire Hospital in Reading, UK
Exclusion criteria: leiomyomata, endometrial or cervical neoplasia, concomitant ovarian pathology, pelvic inflammatory disease or endometriosis
Interventions

Rx 1: endometrial resection, n = 25
Rx 2: abdominal hysterectomy, n = 26
Duration: 12 months (mean) of follow-up

Procedures performed by 'experienced surgeons on routine operating lists'

OutcomesChange in menstrual blood loss
Duration of surgery (minutes)
Duration of hospital stay (days)
Return to work (weeks)
Postoperative complications
Requirement for further surgery
Resource cost of surgery (theatre and ward) (per woman)
NotesEndometrial resection women given an intramuscular injection of medroxyprogesterone acetate 150 mg four to six weeks before surgery to reduce endometrial thickness
Author contacted but no reply received
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomisation sequence not described
Allocation concealment (selection bias)Unclear riskSealed envelope but no other safeguards described
Blinding (performance bias and detection bias)
All outcomes
High riskNot feasible for a comparison of surgical techniques
Incomplete outcome data (attrition bias)
All outcomes
Low riskDropouts minimal and not likely to cause bias
Selective reporting (reporting bias)Unclear riskNo prior protocol identified
Other biasLow riskGroups appeared balanced at baseline, although very few parameters examined

O'Connor 1997

MethodsRandomisation at a ratio of 2:1 from a computer-generated random number sequence, with the code kept at the Royal Free Hospital
Multi-centre, parallel-group with no blinding
Number of women randomly assigned: n = 202
Number of withdrawals: n = 30 (26 before surgery and four lost to follow-up)
Power calculation for sample size performed and analysis by intention to treat
Source of funding: Medical Research Council
ParticipantsWomen 30 to 50 years of age who had symptomatic menorrhagia that required hysterectomy were recruited from several centres in the UK (King's Lynn, Portsmouth, Plymouth, London, Bradford, Chelmsford, Northampton, Birmingham and Exeter)
Inclusion criteria: 30 to 50 years of age, decision to have no more children, regular menstrual cycles of between 21 and 35 days, with each period lasting for less than 50% of the cycle, documented evidence of normal endometrial histology within the previous 12 months and normal cervical smear within the previous three years
Exclusion criteria: serious intercurrent illness, intermenstrual or postcoital bleeding, uterine size corresponding to pregnancy of greater than 12 weeks of gestation, submucous fibroids larger than 5 cm in diameter, adnexal tenderness that is suggestive of pelvic inflammatory disease or endometriosis, major uterovaginal prolapse or severe urinary symptoms, severe premenstrual syndrome or menopausal symptoms
Interventions

Rx 1: transcervical endometrial resection, n = 116
Rx 2: hysterectomy, n = 46 (n = 28 abdominal, n = 28 vaginal)
Duration: two years (median) of follow-up

Surgeons performing TCRE required prior experience of at least 20 procedures. Surgeons performing hysterectomy were 'experienced' or were supervised by an experienced surgeon

OutcomesSatisfaction rate at two years
Quality of life (General Health Questionnaire, Mood scales, Social Adjustment Scale)—these were not entered in this review because the data were in graphical form and were not provided in numerical form by the authors
Duration of surgery (minutes)
Duration of hospital stay (days)
Blood loss (this outcome not entered in the review because SD was too large and data were not available for transformation)
Difficulty of surgery (this outcome not entered in the review)
Complication rate
Requirement for further surgery
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random number sequence
Allocation concealment (selection bias)Low riskCode to randomisation kept separate, with telephoning for next assignment
Blinding (performance bias and detection bias)
All outcomes
High riskNot feasible for a comparison of surgical techniques
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDropouts greater than 10% and reasons not given
Selective reporting (reporting bias)Unclear riskNo prior protocol identified
Other biasLow riskGroups appeared balanced at baseline. No other potential bias identified

Pinion 1994

MethodsRandomisation, ratio of 2:1:1 (hysterectomy:resection:ablation), by a series of numbered opaque envelopes in a random order
Single-centre, parallel-group, no blinding
Number of participants randomly assigned: n = 204
Number of withdrawals: n = 6 (two before surgery and four refused the allocated treatment)
Power calculation for sample size performed and analysis by intention to treat
Source of funding: Scottish Office Home and Health Dept and ICI (Zeneca)
ParticipantsWomen with mean age of 40 years, eligible to undergo hysterectomy for menorrhagia, recruited from the general gynaecology clinics of the Aberdeen Royal Infirmary in Scotland, UK
Inclusion criteria: age < 50 years, weight < 100 kg, clinical diagnosis of dysfunctional uterine bleeding, uterus < 10 weeks of gestational size, normal endometrial histology
No exclusion criteria reported
Interventions

Rx 1: laser ablation (n = 53) or endometrial resection (n = 52)
Rx 2: hysterectomy (n = 87 abdominal, n = 12 vaginal), n = 99
Duration: four years of follow-up

Prior experience of the surgeon not mentioned

OutcomesSatisfaction rate at one and four years
Change in general health
Change in MBL
Duration of surgery (minutes)
Duration of hospital stay (days)
Return to work (weeks)
Complication rate
Quality of life (Hospital Anxiety and Depression Scale, Golombok Rust Inventory of Marital State)
Quality of life (Psychosocial Adjustment to Illness Scale)—this outcome not entered in the review because not enough information provided about categories
Health service costs at one and four years
Participant costs at one year
Requirement for further surgery
NotesAuthor contacted for additional data but no reply received
This trial has four publications using the same study population and assessing different outcomes
Data usually available only for the laser ablation and endometrial resection combined
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandomisation sequence not described
Allocation concealment (selection bias)Low riskSeries of numbered opaque envelopes
Blinding (performance bias and detection bias)
All outcomes
High riskNot feasible for a comparison of surgical techniques
Incomplete outcome data (attrition bias)
All outcomes
Low riskDropouts minimal and unlikely to cause bias
Selective reporting (reporting bias)Unclear riskNo prior protocol identified
Other biasLow riskGroups appeared balanced at baseline and no other potential bias identified

Sesti 2011

Methods

Randomisation by computer-generated sequence of serially numbered opaque envelopes

Single-centre parallel-group with blinding of assessors

Number of women randomly assigned: n = 68

Number of withdrawals: n = 0

Power calculation for sample size performed and analysis by intention to treat

Source of funding: Italian Ministry of University

Participants

Women 35 to 50 years of age with heavy menstrual bleeding, who had failed appropriate first-line oral medical therapy and required surgical treatment

Inclusion criteria: PBAC score ≥ 100 (average of two consecutive cycles), completed family, normal smear, pelvic ultrasound scan and endometrial biopsy

Exclusion criteria: previous endometrial resection/ablation, previous levonorgestrel intrauterine system, any uterine pathology on pelvic ultrasound scan or hysteroscopy, any pathology whereby hysterectomy was indicated, uninvestigated abnormal bleeding or postmenopausal bleeding

Interventions

Rx 1: endometrial ablation via Thermachoice III thermal balloon ablation

Rx 2: laparoscopic subtotal hysterectomy

Duration of follow-up: 24 months

All surgery was performed by the same two surgeons; however, prior experience of the surgeon not mentioned

Outcomes

Primary:

Menstrual bleeding (PBAC score) at three, six, 12 and 24 months

Secondary:

Quality of life (SF-36 score) at 24 months

Improvement in bleeding patterns (frequency and duration of bleeding) at three, six, 12 and 24 months

Haemoglobin levels at three, six, 12 and 24 months

Intensity of postoperative pain

Early postoperative complications

NotesInformation included in the study was sufficient for meta-analysis—not necessary to contact authors
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated randomisation sequence
Allocation concealment (selection bias)Low riskSerially numbered, opaque sealed envelopes
Blinding (performance bias and detection bias)
All outcomes
High riskNot feasible for a comparison of surgical techniques
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll women accounted for in groups to which they were randomly assigned
Selective reporting (reporting bias)Low riskAll prespecified outcomes reported.
Other biasLow riskGroups balanced at baseline. No other potential bias identified

Zupi 2003

Methods

Computer-generated randomisation number sequence

Single-centre, parallel-group, single-blind (assessors of SF-36 results)

Number of women randomly assigned: 203

Number of women analysed: 181

Power calculation for sample size (power of 0.8 for difference in satisfaction rate of 50% between groups)

Analysis was by intention to treat

Source of funding: not reported

Participants

Women with mean age of 43 years with menometrorrhagia unresponsive to medical treatment, recruited between March 1995 and February 1997 from Departmental O and G Clinic in the Tor Vergarta University of Rome, Italy

Inclusion: younger than 50 years of age; weight less than 100 kg; not seeking contraception; normal endometrial histology and Pap smear within the previous six months; uterus not greater than 12 weeks of pregnancy in size; without submucosal fibroids, adnexal masses or endometriosis

Exclusion: no further exclusion criteria reported

Interventions

Rx 1: pretreatment with GnRHa one month before surgery, then hysteroscopic endometrial resection

Rx 2: laparoscopic supracervical hysterectomy

Duration: two years (follow-up at three months, at one and two years)

All surgeons were proficient in both endometrial resection and laparoscopic hysterectomy

Outcomes

Pain (immediately after surgery and then for a week)

Duration of vaginal bleeding

Date resumed normal activities, sexual intercourse, work

Quality of life (SF-36)

Further surgery

Operative outcomes (duration of surgery, blood loss, complications, hospital stay)

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random number sequence
Allocation concealment (selection bias)Unclear riskNot described
Blinding (performance bias and detection bias)
All outcomes
High riskNot feasible for a comparison of surgical techniques. Single blinding of assessors who administered the SF-36, but women who provided the answers knew of their assignment
Incomplete outcome data (attrition bias)
All outcomes
Low riskDropouts minimal and unlikely to cause bias
Selective reporting (reporting bias)Unclear riskNo prior protocol identified
Other biasLow riskGroups appeared balanced at baseline and no other potential bias identified

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Lin 2006Not an RCT
Paddison 2003Not an RCT

Ancillary