Although tubal sterilization procedures are considered to be permanent, requests for reversal of the procedure (re-canalisation) are not infrequent. The reversal procedure can be done either by an open laparotomy or by minimally invasive surgery (laparoscopic or robotic approach).
To compare the relative effectiveness and safety of reversal of tubal sterilization by open laparotomy, laparoscopy and robotically assisted endoscopy.
On 23 October 2012 we searched the Cochrane Menstrual Disorders and Subfertility Review Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 10, 2012); MEDLINE; EMBASE; LILACS; clinical trials registries; regional databases; conference proceedings; and references for relevant published, unpublished and ongoing trials.
Randomised trials comparing the different methods of surgical reversal of tubal sterilisation.
Data collection and analysis
No trials that met the selection criteria were identified.
No data for evaluation were obtained
Currently there is no evidence from randomised controlled trials to recommend or refute the use of a minimally invasive surgical approach (laparoscopic or robotic) or open surgery for reversal of tubal sterilization. There is a need for well conducted and reported randomised clinical trials to generate reliable evidence to inform clinical practice.
Chirurgie mini-invasive versus chirurgie ouverte pour traiter l'inversion de la stérilisation tubaire
Bien que les procédures de stérilisation tubaire soient considérées comme étant définitives, les demandes d'inversion de la procédure (recanalisation tubaire) ne sont pas rares. La procédure d'inversion peut être pratiquée soit par une laparotomie effractive soit par une chirurgie mini-invasive (approche laparoscopique ou robotisée).
Comparer l'efficacité relative et la sécurité d'emploi de l'inversion de la stérilisation tubaire par laparotomie effractive, laparoscopie et endoscopie robotisée.
Stratégie de recherche documentaire
Le 23 octobre 2012, nous avons effectué des recherches dans le registre spécialisé du groupe Cochrane sur les troubles menstruels et de la fertilité ; le registre Cochrane des essais contrôlés (CENTRAL) dans The Cochrane Library (numéro 10, 2012) ; MEDLINE ; EMBASE ; LILACS ; les registres d'essais cliniques ; les bases de données régionales ; les actes de conférences ; et les références d'essais publiés, non publiés et en cours pertinents.
Critères de sélection
Les essais randomisés comparant les différentes méthodes d'inversion chirurgicale de la stérilisation tubaire.
Recueil et analyse des données
Aucun essai répondant aux critères de sélection n'a été identifié.
Nous n'avons obtenu aucune donnée à évaluer.
Conclusions des auteurs
À l'heure actuelle, il n'existe aucune preuve issue d'essais contrôlés randomisés pour recommander ou réfuter l'utilisation d'une approche de chirurgie mini-invasive (laparoscopique ou robotisée) ou d'une chirurgie ouverte pour l'inversion de la stérilisation tubaire. Il est nécessaire de réaliser des essais cliniques randomisés bien menés et utilisant une notification des résultats conforme afin de générer des données fiables en vue d'orienter la pratique clinique.
Reversal of sterilization by open versus minimally invasive surgery
Reversal of sterilization can be done either by open surgical methods or by a minimally invasive approach. Randomised controlled trials evaluating the benefits of these procedures are not available. Research in this field is recommended.
Inversion de la stérilisation par chirurgie ouverte versus chirurgie mini-invasive
L'inversion de la stérilisation peut être effectuée soit par des techniques de chirurgie ouverte soit par une approche de chirurgie mini-invasive. Des essais contrôlés randomisés évaluant les bénéfices de ces procédures ne sont pas disponibles. Il est recommandé de mener des recherches dans ce domaine.
Notes de traduction
Traduit par: French Cochrane Centre 1st March, 2013 Traduction financée par: Pour la France : Ministère de la Santé. Pour le Canada : Instituts de recherche en santé du Canada, ministère de la Santé du Québec, Fonds de recherche de Québec-Santé et Institut national d'excellence en santé et en services sociaux.
Tubal sterilization is a popular method of family planning and is usually done after childbirth or miscarriage, during caesarian section or in what would have been the interval between pregnancies. Various surgical techniques exist and can be broadly classified into either open surgical methods or endoscopic procedures. Commonly carried out open surgical methods include the Pomeroy, Parkland, Irving and Madlener procedures and fimbriectomy (removal of the terminal end of the tube). Laparoscopic tubal sterilization is popular, with tubal continuity being disrupted through the use of loops, clips or electro-cautery.
Although tubal sterilization procedures are considered to be permanent, requests for reversal of the procedure (re-canalisation) are not infrequent (1% to 5%) (Siegler 1985; Hillis 1999). The reversal procedure can be done either by an open laparotomy or by minimally invasive surgery (laparoscopic or robotic approach). The damaged part of the tube is excised and the remaining patent ends are brought together and sutured thus re-establishing tubal patency. Use of a microscope or loupes for magnification has been shown to be beneficial during open surgery (Gomel 1980; Henderson 1984).
Description of the condition
The success of reversal procedures depends upon a variety of factors. Important factors include the woman's age, the method of sterilization, length of time from the original procedure to reversal and the remaining length of the tube following the reversal of sterilization (Rouzi 1995; Glock 1996; Hanafi 2003). Some studies have found a decline in pregnancy rates following a reversal procedure in women older than 36 years (Hanafi 2003; Gordts 2009). Increased duration of sterilization (> five years) and a short tubal length after reversal (< 4 cm) were also found to have a negative influence on the success rate of the reversal procedure (Rock 1987; Gordts 2009). Higher pregnancy rates have been obtained following reversal procedures in women who have undergone clip or Falope ring sterilization compared with coagulation or Pomeroy's technique (Rock 1987; Gordts 2009). Other factors like use of operating loupes or a microscope, fine sutures, operator experience and surgical techniques play an important part in the success of reversal procedures.
Comprehensive counselling sessions are essential for women requesting a reversal of the sterilization procedure to ensure awareness of the benefits and possible complications. This is especially so in women with a history of a previous caesarean section. The need to undertake a laparotomy for the reversal procedure followed by the likelihood of a repeat caesarean section once conception takes place has to be emphasized. Repeated laparotomy and caesarean section could lead to increased surgical morbidity and will be detrimental to patient health.
Description of the intervention
The traditional approach has been to perform a laparoscopy to determine operability followed by an open laparotomy procedure using microsurgical techniques. Pregnancy rates of 70% to 80% have been achieved in women with a good prognosis (Siegler 1985; Kim 1997; Gordts 2009).
With the availability of better laparoscopic equipment (a three chip charge-coupled device (CCD) camera, wide screen high definition television monitors, precision instruments) laparoscopic surgeons are now advocating laparoscopic tubal re-anastomosis. This approach has the advantage of smaller incisions, decreased likelihood of wound infections, less post-operative discomfort and a quicker recovery with return to normal activities (Yoon 1999a). Better visualisation as a result of laparoscopic magnification and gentle handling of tissues are other advantages. A laparoscopic approach would be especially beneficial when there is a history of previous abdominal surgery as a repeat laparotomy can be avoided. However, laparoscopic tubal surgery is technically difficult and requires a high level of expertise and proficiency. Acceptance of any surgical procedure depends upon its safety and success. Several recent reports suggest conception and ongoing pregnancy rates of above 70% with laparoscopy, which are comparable to conventional open surgical techniques and occur without an increase in other pregnancy complications like miscarriages or ectopic pregnancies (Yoon 1999a; Cha 2001). An important drawback of the minimally invasive approach is the need for expensive equipment and a high level of technical expertise. In comparison to the traditional open method of re-canalisation surgery, attaining proficiency in the laparoscopic method has a long learning curve. This makes these facilities available only in selected centres.
The recent introduction of robotic surgery for reversal of sterilization has added a new dimension to endoscopic surgery. The limitations of conventional laparoscopic surgery are the challenging learning curve and the difficulty in precision suturing of delicate tissues due to limitations in the freedom of movement of laparoscopic instruments. Although expensive, robotic surgery has been described as being akin to open surgery in terms of instrument movement and usage, with a freedom of movement similar to that of the human wrist (Goldberg 2003; Dharia 2008).
How the intervention might work
Women who have undergone tubal surgery for family planning and then request reversal of the procedure need to undergo surgery to restore tubal patency. This can be done either by open laparotomy or by a minimally invasive procedure, which could be either by laparoscopy or robotic surgery. Fertility restoration can be achieved by re-establishing tubal patency in the previously disconnected or occluded fallopian tubes.
Why it is important to do this review
Several publications have appeared describing minimally invasive techniques for reversal of tubal sterilization, with results comparable to an open surgical approach (Yoon 1997; Yoon 1999a; Goldberg 2003; Dharia 2008). The purpose of this review was to evaluate the different methods of tubal reversal, namely open surgery, a laparoscopic approach and robotic endoscopic surgery procedures. Reliable evidence on the safety and efficacy of these procedures would aid decision making by surgeons, health policy makers and women seeking reversal of tubal sterilization.
To compare the relative effectiveness and safety of reversal of tubal sterilization by open laparotomy, laparoscopy and robotically assisted endoscopy.
Criteria for considering studies for this review
Types of studies
Only randomised controlled trials (RCTs) were eligible for inclusion. Quasi and pseudo-randomised trials (where allocation to treatment arms was by methods that were predictable) were excluded. Crossover trials were excluded as the design was not valid in this context.
Types of participants
Pre-menopausal women who had undergone tubal sterilization and were seeking reversal of tubal sterilization.
Types of interventions
Trials comparing the following interventions were eligible for inclusion.
Open laparotomy versus laparoscopic tubal reversal.
Open laparotomy versus robotically assisted endoscopic tubal reversal.
Laparoscopic versus robotically assisted endoscopic tubal reversal.
Types of outcome measures
Live birth rate: births in which a fetus shows signs of life after expulsion or extraction from the mother after 20 weeks of gestation, per woman randomised
1. Fertility outcomes
Clinical pregnancy rate: ultrasound evidence of gestational sac, per woman randomised
Ongoing pregnancy rate: viable pregnancy, as shown by ultrasound, beyond 12 weeks of gestation, per woman randomised
Time to pregnancy (months)
Miscarriage rate: expulsion of fetus before 20 weeks gestation, per intrauterine pregnancy
Ectopic pregnancy rate: pregnancy in which implantation takes place outside the uterine cavity
Pre-term birth rate: births which takes place at least after 20, but less than 37, completed weeks of gestation, per woman randomised
2. Surgical outcomes
Operating time (minutes)
Duration of hospital stay (days)
Return to normal activity (days)
Tubal patency on hysterosalpingogram
Search methods for identification of studies
We searched for relevant trials regardless of language or publication status (published, in press and in progress).
In consultation with the Trials Search Coordinator of the Menstrual Disorders and Subfertility Group, on 23 October 2012 we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 10, 2012), the Menstrual Disorders and Subfertility Group Specialised Register, MEDLINE, EMBASE and PsycINFO. The Menstrual Disorders and Subfertility Specialised Register search string used is described in Appendix 1; as are the search strategies for EMBASE (Appendix 2), PsycINFO (Appendix 3), CENTRAL (Appendix 4) and MEDLINE (Appendix 5). The search terms were combined with the Cochrane highly sensitive search strategy for identifying randomised trials in MEDLINE (sensitivity-maximising version, 2008 revision) in the Ovid format (Higgins 2011).
We also searched the South Asian Database of Controlled Clinical Trials (www.cochrane-sadcct.org) for trials from the south Asian region that were published in journals not indexed in MEDLINE or EMBASE.
Searching other resources
We checked the reference lists of all the studies identified by the above methods.
We handsearched the conference abstracts and announcements (1995 to 2012) from:
Two review authors (KG, MSK) independently inspected the citations identified from the search. Potentially relevant abstracts were identified and full papers ordered and assessed for inclusion in accordance with the criteria defined. Disagreements during this process were resolved by discussion with the third author (PT) or by contacting the trial authors for clarifications.
Data extraction and management
We planned to independently extract the data from included trials using a data extraction form designed and pilot tested by the authors. We intended to contact the authors of trials with insufficient or missing data for more information. Disagreements, if any, would have been resolved by referring to the trial report and through discussions. One author (MSK) would have entered the data into Review Manager (RevMan) Version 5.2 (Review Manager 2011) and this would have been independently checked by the other two authors.
For dichotomous outcome measures, we planned to record the number of participants experiencing the event and the number analysed in each group. For continuous outcome measures, we planned to extract arithmetic means and standard deviations for each group together with the numbers analysed in each group. If the data were reported using geometric means, we would have recorded this information and extracted a standard deviation on the log scale; we also would have extracted ranges if medians were used.
Summarising and interpreting results
We intended to use the GRADE approach to interpret findings (Higgins 2011) and to use the GRADE profiler (GRADE 2004) to import data from RevMan 5 to create a 'Summary of findings' table. This would have included information concerning the quality of the evidence, the magnitude of effect of the interventions examined and the sum of the available data on all important outcomes (live birth rate, clinical pregnancy rate, ectopic rate, operating time, duration of hospital stay, post-operative pain and time to pregnancy) from each included study in the comparison. We would have used these summary findings to interpret the results and frame the conclusions.
Assessment of risk of bias in included studies
We planned to independently assess the risk of bias in each included study. Disagreements, if any, would have been resolved by: referring to the trial report, correspondence with the authors of the report, and through discussions. We would have assessed each study on the domains of: sequence generation; allocation concealment; blinding of participants, personnel and outcome assessors; incomplete outcome data; selective reporting; and other sources of bias. For each of these components, we would have assigned a judgment regarding the risk of bias as 'high', 'low', or 'unclear' using criteria laid down in Higgins 2011. We would have recorded these assessments in the standard 'risk of bias' tables in Review Manager 2011 and summarised the risk of bias for each study in a summary risk of bias figure and graph.
Measures of treatment effect
We intended to extract the data from each included trial to calculate the odds ratio and 95% confidence interval for dichotomous data and mean differences with 95% confidence intervals for continuous data. The standardised mean difference would have been used for continuous data presented on different scales, such as pain.
Unit of analysis issues
The primary analysis would have been per woman randomised.
Dealing with missing data
We intended to extract dichotomous data according to the intention-to-treat principle whereby the analysis would include all the participants in the groups to which they were originally randomised. We planned to write to the authors of trials to seek missing data. We would have separately analysed the trials from which extraction of the data according to the intention-to-treat principle was not possible. For continuous data we planned to use the results as presented and not make any assumptions about missing data, though the information would have been reported in the assessment of risk of bias in included studies and in the assessment of reporting biases. For continuous data that were missing standard deviations we planned to either calculate them from other available data, such as standard errors, or impute them using methods suggested in Higgins 2011.
Assessment of heterogeneity
We intended to assess heterogeneity amongst trials by: inspecting forest plots to look for overlapping confidence intervals; applying the Chi2 test, with a P value of 0.05 indicating statistical significance; and using the I2 statistic, with a value of 50% denoting a moderate level of heterogeneity. If heterogeneity was detected and it was still considered clinically meaningful to combine studies, then we would have used a random-effects model.
Assessment of reporting biases
We would have assessed the included studies for adequacy of reporting data for pre-stated outcomes and for selective reporting of outcomes. We would have noted judgements based on the risk of selective reporting in the 'Risk of bias' table that follows each study in the 'Characteristics of included studies' table.
We would have considered the likelihood of publication bias by using funnel plots provided that there were at least 10 trials assessing the particular outcomes, keeping in mind that heterogeneity of results or differences in the methodological quality could affect funnel plot symmetry.
We would have analysed data using Review Manager 2011. Dichotomous data would have been presented and combined using odds ratios, and continuous data would have been summarised by arithmetic means and standard deviations using mean differences; both would be accompanied by 95% confidence intervals.
Arithmetic means and standard deviations used to summarise continuous data are assumed to be normally distributed; however, sometimes these summary statistics are incorrectly used when the data are not normally distributed. Therefore, when arithmetic means were reported we intended to check the normality of the data by calculating the ratio of the mean over the standard deviation. If this ratio (mean/standard deviation) was less than two, then it would be likely that the data were skewed and so we planned not to combine such data in a meta-analysis. With minor degrees of skew it is possible to combine the data in a meta-analysis, and when the degree of skew is mild (ratio of mean/standard deviation was more than one) the data from these studies would have been combined with normally distributed data.
Subgroup analysis and investigation of heterogeneity
We would have used a fixed-effect model when there was no heterogeneity. Where heterogeneity was significant (I2 ≥ 50%) we would have used the random-effects model if the trials were sufficiently similar clinically to pool and the resulting estimates were still interpretable. If severe heterogeneity was present (I2 ≥ 75%) and could not be explained by differences across the trials in terms of clinical or methodological features, or by subgroup analyses (see below), we would not have combined the trials in a meta-analysis but would have presented the results in a forest plot.
The sterilization procedure used could affect the outcome of the reversal procedure, as would the age of the patient and the duration of follow up after the procedure. If there were sufficient trials and data were available, we intended to explore the following potential sources of heterogeneity using subgroup analyses.
Woman's age (less than or greater than 35 years).
Time from sterilization to reversal (five years or less versus more than five years).
Method of sterilization (laparoscopic versus open methods of sterilization).
If there were a sufficient number of trials, we intended to conduct a sensitivity analysis to investigate the robustness of the results to the components of the risk of bias assessment. This would involve analysis based on generation of the randomisation sequence, concealment of the allocation sequence, presence of missing data and protocol deviations. We would have removed poor quality studies from the pooled analysis in order to assess any differences in the overall results.
Description of studies
Results of the search
Our search retrieved 17 reports of studies (Figure 1). Only three studies were considered potentially eligible but were excluded after obtaining the full texts, and the reasons for their exclusion are documented in the Characteristics of excluded studies table.
We are not aware of any ongoing trials and no studies currently await classification.
No randomised controlled trials fulfilling the inclusion criteria of this review were identified.
One study which compared robotic tubal anastomosis versus open surgery was not included as it was a cohort study and not a randomised trial (Dharia 2008). One RCT (Rock 1984) was excluded since it compared the loupe versus microscopy for microsurgical anastomosis for reversal of tubal sterilization; this trial did not have arms comparing laparoscopic versus open or robotic surgical reversal of tubal sterilization. The retrospective study by Owens 2012 comparing the traditional open microsurgical method versus the robotic assisted laparoscopic approach for reversal of tubal sterilization was also excluded.
Risk of bias in included studies
Incomplete outcome data
Other potential sources of bias
Effects of interventions
No trials were included, precluding any evaluation of the effects of interventions.
Summary of main results
We were unable to identify any RCTs comparing laparoscopic, open or robotic surgical techniques to reverse the effects of tubal sterilization procedures.
Overall completeness and applicability of evidence
Quality of the evidence
Potential biases in the review process
We searched multiple overlapping databases and additional sources and feel that our search was sufficiently detailed to identify any relevant trials. It is still possible, however, that we may have missed unpublished trials that were not reported in conferences, or were reported in conferences that we did not search. In future updates of this review we hope to identify eligible trials, if any, by widening our search strategy.
Since there were no RCTs identified, we do not feel that there are other potential biases in the review process.
Agreements and disagreements with other studies or reviews
We excluded Dharia 2008, which was a prospective cohort study comparing robotic microsurgical tubal re-anastomosis with the same procedure done by open surgery. Robotic surgery was found to be feasible and cost effective with results comparable to the open approach. The study by Owens 2012 was a retrospective analysis of patients undergoing microsurgical open surgery or robot assisted laparoscopic reversal of tubal ligation. The authors found no difference in the pregnancy outcomes following both the approaches.
In a meta-analysis by Ia Grange J 2012, only three retrospective studies were found comparing tubal re-anastomosis by the open method versus the laparoscopic method and the authors found no difference in the intrauterine pregnancy and ectopic pregnancy rates among the two groups.
Implications for practice
Minimally invasive surgery is currently a popular method of surgical intervention for reversal of tubal sterilization. Although laparoscopic surgery is widespread world wide, robotic surgery is emerging as an alternative, even in the developing world. Nevertheless, the effectiveness of any new procedure needs to be compared against established methods. We were unable to identify any randomised controlled trials evaluating these procedures, and hence we are unable to provide any evidence to inform practice.
Implications for research
Randomised controlled trials comparing different approaches for tubal re-anastomosis are required. Comparison of different surgical procedures is a complex issue as the skill of the surgeon plays an important role in outcome measures. A surgeon who has acquired the skills of minimally invasive surgery, after a long and tedious learning curve, is not likely to perform open surgery for this procedure. In this context, a properly conducted and reported randomised trial will need to compare the skills of a surgeon who is adept at doing open surgery against a skilled minimally invasive surgeon. A well designed trial, perhaps powered for non-inferiority, comparing these procedures would be valuable in informing guidelines of management that are based on reliable evidence. Apart from the outcomes (for example ongoing pregnancy rates, live birth rates) that assess the efficacy of such surgical procedures, future trials should also evaluate resource use, resource costs and the cost effectiveness of the procedures.
This review is an outcome of a protocol development workshop organized by the South Asian Cochrane Network & Centre at the Christian Medical College, Vellore.
We would also like to acknowledge the support provided by Marian Showell (Trials Search Coordinator from the Cochrane Menstrual Disorders and Subfertility Group) for the design of the search strategy used in this review.
Appendix 1. Menstrual Disorders and Subfertility database search string
Keywords CONTAINS "tubal anastomosis" or "tubal factor" or "tubal occlusion" or "tubal patency" or "tubal reconstruction" or "tubal subfertility" or "tuboplasty" or "tubal infertility" or "tubal disorders" or "tubal anastomosis" or "Fallopian tube obstruction" or "recanalization" or "recatheterisation" or "reversal of sterilisation" or Title CONTAINS"tubal anastomosis" or "tubal factor" or "tubal occlusion" or "tubal patency" or "tubal reconstruction" or "tubal subfertility" or "tuboplasty" or "tubal infertility" or "tubal disorders" or "tubal anastomosis" or "Fallopian tube obstruction" or "recanalization" or "recatheterisation" or "reversal of sterilisation"
Keywords CONTAINS "laparotomy"or "open surgery" or "mini-laparotomy" or "minilaparotomy" or "microsurgery" or "surgery" or "laparoscopic" or "laparoscopic repair" or "laparoscopic surgery" or "laparoscopy" or "robotic control" or Title CONTAINS "laparotomy" or "open surgery" or "mini-laparotomy" or "minilaparotomy" or "microsurgery" or "surgery" or"laparoscopic" or "laparoscopic repair" or "laparoscopic surgery" or "laparoscopy" or "robotic control"