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Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding

  1. Rosalie J Fergusson1,
  2. Anne Lethaby2,*,
  3. Sasha Shepperd3,
  4. Cindy Farquhar4

Editorial Group: Cochrane Gynaecology and Fertility Group

Published Online: 29 NOV 2013

Assessed as up-to-date: 30 OCT 2013

DOI: 10.1002/14651858.CD000329.pub2


How to Cite

Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 2013, Issue 11. Art. No.: CD000329. DOI: 10.1002/14651858.CD000329.pub2.

Author Information

  1. 1

    Auckland District Health Board, Obstetrics and Gynaecology, Auckland City Hospital, Auckland, New Zealand

  2. 2

    University of Auckland, Department of Obstetrics and Gynaecology, Auckland, New Zealand

  3. 3

    University of Oxford, Nuffield Department of Population Health, Oxford, Oxfordshire, UK

  4. 4

    University of Auckland, Obstetrics and Gynaecology, Auckland, New Zealand

*Anne Lethaby, Department of Obstetrics and Gynaecology, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. a.lethaby@auckland.ac.nz.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 29 NOV 2013

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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


InterventionsRx 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

MethodsRandomisation 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


InterventionsRx 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


OutcomesPain, 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


InterventionsRx 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


InterventionsRx 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


InterventionsRx 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


InterventionsRx 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

MethodsRandomisation 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


ParticipantsWomen 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


InterventionsRx 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


OutcomesPrimary:

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

MethodsComputer-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


ParticipantsWomen 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


InterventionsRx 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


OutcomesPain (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

 
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)5Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Within one year of follow-up
4650Risk Ratio (M-H, Fixed, 95% CI)0.89 [0.85, 0.93]

    1.2 At two years of follow-up
2292Risk Ratio (M-H, Fixed, 95% CI)0.92 [0.86, 0.99]

    1.3 At four years of follow-up
2237Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.88, 0.99]

 2 PBAC score (continuous data)1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    2.1 At one year of follow-up
168Mean Difference (IV, Fixed, 95% CI)24.4 [16.01, 32.79]

    2.2 At two years of follow-up
168Mean Difference (IV, Fixed, 95% CI)44.0 [36.09, 51.91]

 3 Proportion requiring further surgery for HMB8Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    3.1 Within one year after surgery
6887Risk Ratio (M-H, Fixed, 95% CI)14.94 [5.24, 42.57]

    3.2 At two years after surgery
6930Risk Ratio (M-H, Fixed, 95% CI)23.36 [8.30, 65.75]

    3.3 At three years after surgery
1172Risk Ratio (M-H, Fixed, 95% CI)11.10 [1.54, 80.14]

    3.4 At four years after surgery
1197Risk Ratio (M-H, Fixed, 95% CI)36.32 [5.09, 259.21]

 4 Proportion satisfied with treatment5Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    4.1 At one year of follow-up
4739Risk Ratio (M-H, Fixed, 95% CI)0.94 [0.88, 1.00]

    4.2 At two years of follow-up
4567Risk Ratio (M-H, Fixed, 95% CI)0.87 [0.80, 0.95]

    4.3 At four years of follow-up
2246Risk Ratio (M-H, Fixed, 95% CI)0.89 [0.77, 1.03]

 5 Adverse events—short term (intraoperative and immediate postoperative)6Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    5.1 Sepsis
4621Risk Ratio (M-H, Fixed, 95% CI)0.19 [0.12, 0.31]

    5.2 Haemorrhage
3555Risk Ratio (M-H, Fixed, 95% CI)0.69 [0.32, 1.46]

    5.3 Blood transfusion
4751Risk Ratio (M-H, Fixed, 95% CI)0.20 [0.07, 0.59]

    5.4 Pyrexia
3605Risk Ratio (M-H, Fixed, 95% CI)0.17 [0.09, 0.35]

    5.5 Vault haematoma
5858Risk Ratio (M-H, Fixed, 95% CI)0.11 [0.04, 0.34]

    5.6 Wound haematoma
1202Risk Ratio (M-H, Fixed, 95% CI)0.03 [0.00, 0.53]

    5.7 Anaesthetic
1202Risk Ratio (M-H, Fixed, 95% CI)0.18 [0.01, 3.80]

    5.8 Fluid overload
3611Risk Ratio (M-H, Fixed, 95% CI)9.27 [2.17, 39.64]

    5.9 Perforation
2430Risk Ratio (M-H, Fixed, 95% CI)5.05 [0.61, 42.16]

    5.10 Gastrointestinal obstruction/ileus
1202Risk Ratio (M-H, Fixed, 95% CI)0.46 [0.04, 5.01]

    5.11 Laparotomy
2383Risk Ratio (M-H, Fixed, 95% CI)0.39 [0.08, 1.97]

    5.12 Cystotomy
1228Risk Ratio (M-H, Fixed, 95% CI)0.21 [0.01, 4.42]

    5.13 Cervical laceration
2409Risk Ratio (M-H, Fixed, 95% CI)3.16 [0.33, 30.10]

    5.14 Cardiorespiratory event
1228Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.01, 2.93]

    5.15 Thromboembolic event
1228Risk Ratio (M-H, Fixed, 95% CI)0.21 [0.01, 4.42]

    5.16 Readmission/return to surgery
1228Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.01, 2.93]

 6 Adverse events—long term (after hospital discharge)2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    6.1 Sepsis
1172Risk Ratio (M-H, Fixed, 95% CI)0.27 [0.13, 0.58]

    6.2 Haematoma
2368Risk Ratio (M-H, Fixed, 95% CI)0.59 [0.15, 2.37]

    6.3 Haemorrhage
1196Risk Ratio (M-H, Fixed, 95% CI)2.94 [0.12, 71.30]

 7 Quality of life scores (continuous data)6Mean 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 Functioning
1181Mean Difference (IV, Fixed, 95% CI)-21.20 [-24.73, -17.67]

    7.4 SF-36 at one year—Mental Health
2385Mean Difference (IV, Fixed, 95% CI)-1.53 [-5.06, 2.01]

    7.5 SF-36 at one year—Energy
2211Mean Difference (IV, Fixed, 95% CI)-10.99 [-14.45, -7.53]

    7.6 SF-36 at one year—Pain
2391Mean Difference (IV, Fixed, 95% CI)-1.91 [-5.67, 1.86]

    7.7 SF-36 at one year—General Health Perception
2385Mean Difference (IV, Fixed, 95% CI)-7.27 [-10.72, -3.81]

    7.8 SF-36 at one year—Physical Functioning
1181Mean 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 Functioning
3300Mean Difference (IV, Fixed, 95% CI)-10.06 [-13.55, -6.58]

    7.12 SF-36 at two years—Mental Health
4509Mean Difference (IV, Fixed, 95% CI)2.39 [-0.61, 5.40]

    7.13 SF-36 at two years—Energy
4513Mean Difference (IV, Fixed, 95% CI)-2.01 [-5.41, 1.40]

    7.14 SF-36 at two years—Pain
4513Mean Difference (IV, Fixed, 95% CI)-9.50 [-12.80, -6.21]

    7.15 SF-36 at two years—General Health Perception
4509Mean Difference (IV, Fixed, 95% CI)-7.42 [-10.64, -4.20]

    7.16 SF-36 at two years—Physical Functioning
3300Mean Difference (IV, Fixed, 95% CI)-9.29 [-12.80, -5.78]

    7.17 GR inventory scores at one year after surgery
1182Mean Difference (IV, Fixed, 95% CI)0.0 [-1.75, 1.75]

    7.18 Euroqol score within one year after surgery
2347Mean Difference (IV, Fixed, 95% CI)-3.24 [-8.35, 1.88]

    7.19 Euroqol scores at two years after surgery
2368Mean Difference (IV, Fixed, 95% CI)-1.96 [-5.60, 1.67]

    7.20 SSR score at two years after surgery
177Mean Difference (IV, Fixed, 95% CI)-3.70 [-11.17, 3.77]

    7.21 Total HAD scores at two years after surgery
177Mean Difference (IV, Fixed, 95% CI)-1.5 [-4.32, 1.32]

    7.22 Anxiety HAD scores at two and four years after surgery
2259Mean Difference (IV, Fixed, 95% CI)-0.67 [-1.64, 0.30]

    7.23 Depression HAD scores at two and four years after surgery
2259Mean Difference (IV, Fixed, 95% CI)-0.00 [-0.10, 0.09]

 8 Quality of life (proportion with improvement)2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    8.1 Proportion with improvement in pain two years after surgery
159Risk Ratio (M-H, Fixed, 95% CI)1.60 [0.55, 4.63]

    8.2 Proportion with improvement in general health one year after surgery
1185Risk Ratio (M-H, Fixed, 95% CI)4.17 [1.47, 11.85]

    8.3 Proportion with improvement in general health four years after surgery
1146Risk Ratio (M-H, Fixed, 95% CI)2.76 [0.93, 8.17]

 9 Duration of surgery (minutes)7Mean Difference (IV, Random, 95% CI)Totals not selected

 10 Time to return to work (weeks)5Mean Difference (IV, Random, 95% CI)Totals not selected

 11 Time to return to normal activity (days)4Mean Difference (IV, Random, 95% CI)Totals not selected

 12 Duration of hospital stay (days)7Mean Difference (IV, Random, 95% CI)Totals not selected

 13 Total health service cost per womanOther dataNo numeric data

 14 Total individual cost per womanOther dataNo numeric data

 
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 1993FOUR 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 1994ONE 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 1994ONE 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.

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

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

ControlEndometrial resection/ablation

Woman's perception (proportion with improvement in bleeding symptoms)—within one year of follow-up978 per 1,000890 per 1,000
(783 to 949)
RR 0.91
(0.8 to 0.97)
650
(4 studies)
⊕⊕⊝⊝
low1,2

PBAC score (continuous data)—at one year of follow-upMean 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)
⊕⊕⊕⊝
moderate1

Adverse eventsshort term (intraoperative and immediate postoperative)sepsis 319 per 1,00061 per 1,000
(38 to 99)
RR 0.19
(0.12 to 0.31)
621
(4 studies)
⊕⊕⊕⊝
moderate2

Proportion requiring further surgery for HMB—within one year after surgery2 per 1,000336 per 1,000
(13 to 103)
RR 14.94
(5.24 to 42.57)
887
(6 studies)
⊕⊕⊝⊝
low1,4

Proportion satisfied with treatment—at one year of follow-up820 per 1,000771 per 1,000
(721 to 820)
RR 0.94
(0.88 to 1)
739
(4 studies)
⊕⊕⊕⊝
moderate1

*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.

 1Lack of blinding (although unfeasible) is likely to bias women's responses.
2Significant heterogeneity.
3Result suggests incomplete operation—rare.
4Wide confidence interval.