Are evidence-based vasectomy surgical techniques performed in low-resource countries?

Background: Research evidence published 10 to 15 years ago has shown that the type of vasectomy surgical technique performed can influence the effectiveness and the safety of the procedure. The objective of this study was to determine if evidence-based vasectomy surgical techniques are integrated in the vasectomy programs of selected low-resource countries. Methods: The surgical techniques recommended to perform the two steps of the vasectomy procedure (isolation/exposition and occlusion of the vas deferens) were extracted from current evidence-based clinical practice guidelines. Documents describing male sterilisation standards and practice from Kenya, Rwanda, India, Nepal, Mexico, Honduras, Colombia and Haiti were reviewed to assess adequacy with international guideline recommendations. Results: Best recommended techniques are 1) a minimally invasive technique including the no-scalpel technique (known as the no-scalpel vasectomy (NSV)) to isolate and expose the vas deferens, and 2) cautery of the mucosa of the vas preferably combined with interposition of the fascia (FI) to occlude the vas deferens. The NSV is largely adopted and performed to isolate the vas in selected low-resources countries. Ligation and excision (LE) of a small segment of the vas deferens combined with FI is the most common vas occlusion technique mentioned in the country standards. Cautery as recommended in the guidelines is seldom used in selected countries. Conclusions: Effective and adapted vasectomy vas occlusion techniques are available, but are still underused in many low-resource countries. Providing the most effective vasectomy surgical techniques increases users’ confidence and satisfaction regarding male sterilization and may lead to higher acceptability and uptake.


Introduction
Vasectomy is generally regarded as a simple, safe, very effective, and highly cost-effective contraceptive method. In the early 2000s, randomized trials 1,2 , comparative studies 3-5 , systematic reviews 6,7 and expert consultations 8 showed that specific surgical techniques are associated with better safety and effectiveness of the procedure. More recently published North American and European practice guidelines on vasectomy based their recommendations on these findings 9-12 .
Although the uptake of vasectomy is low in most low-resource countries, some have active vasectomy programs 13 . The objectives of this study were to determine 1) which vasectomy surgical techniques are recommended in evidence-based practice guidelines to reduce surgical complications (bleeding and infections) and to maximize occlusion and contraceptive effectiveness, and 2) if these techniques are integrated in the vasectomy norms and standards, and current practice of targeted low-resource countries.

Recommended techniques
The recommended techniques of the two surgical steps of the vasectomy procedure (isolation/exposition and occlusion of the vas deferens) were extracted by the author from the following vasectomy practice guidelines: the European Association of Urology (2012) 9 , American Urological Association (2012,2015) 10 , the Faculty of Sexual & Reproductive Healthcare (FSRH), the standard-setting organisation for family planning and sexual health in United Kingdom (2104) 11 , and the Canadian Urological Association (2016) 12 . The level of evidence, strength of recommendation and the most relevant underlying evidence from systematic reviews supporting the recommendations was also extracted.
Data from low-resource countries A convenience sample of eight low-resource countries from Africa, Asia and America known by the author to provide vasectomy services on different scales was selected. India, Nepal, Mexico, and Colombia (through Profamilia, a non-profit nongovernmental organisation) have large and structured vasectomy programs with thousands of men vasectomized each year while private or governmental smaller scale initiatives exist in Kenya, Rwanda, Honduras and Haiti.
For each country, the most recent document describing vasectomy techniques that should be used (national standards/norms) and/or that are performed was first identified through personal contact with individuals from or acquainted with vasectomy in selected countries. In addition, in order to validate the currency of documents retrieved, a Google search was performed twice, in spring 2018 and April 2019, using the name of the country, "vasectomy" or "male sterilization", and key words from the title of documents already identified. No date limits were imposed. The retrieved Google search pages were scanned until no more related documents were found. PubMed or Google Scholar search was not performed because, as expected, none of the relevant documents initially retrieved was published as peerreviewed article.
The surgical techniques recommended and/or commonly performed to isolate/expose (classic technique with a scalpel, NSV) and to occlude the vas (simple LE, LE+FI, cautery) in the selected countries were extracted from the retrieved documents. Additional information on the surgical techniques commonly performed as obtained by personal contact with key informants was also reported. Guideline recommendations were compared to and contextualized with vasectomy techniques performed in the selected countries.

Guideline recommendations
Excerpts of recommendations from the four practice guidelines are presented in Table 1. Although the assessment of the evidence and the strength of the recommendations vary across the four guidelines, they all agree that a minimally invasive (MIV) technique including the no-scalpel technique (known as the no-scalpel vasectomy (NSV)) should be performed to isolate and expose the vas deferens. The criteria of a MIV technique are: 1) a skin opening of ≤10 mm, 2) minimal dissection of the vas and perivasal tissues, and 3) no use of skin sutures 10 . Among the MIV techniques, NSV is the most studied. Two systematic reviews concluded that NSV -based on high-quality evidence -is significantly associated with a lower risk of surgical complications, namely bleeding and/or hematomas 6,7 .
The guidelines also all agree that cautery of the mucosa of the vas lumen, preferably combined with interposing the fascia between the divided ends of the vas (fascial interposition (FI)), should be used to occlude the vas. Moderate-quality evidence from cohort studies showed that the "classical" ligation and excision (LE) technique consisting in putting two ligatures on the vas deferens and excising a small (1 cm) vas segment in between is associated with a high risk of occlusion failure based on post-vasectomy semen analysis, from 8 to 13% 2,3,14-16 , and contraceptive failure, from 4% after 3 years to 9% after 10 years [17][18][19] . Although a high-quality randomized trial 2 demonstrated that LE combined with FI on the testicular end can reduce the risk of failure by 50%, occlusion failure rate remained high at 5.9% (95% confidence interval 3.8% to 8.6%). Moderate quality evidence based on comparative cohort studies showed that

Amendments from Version 1
The changes in the second version of the article were the following: 1) I indicated in the text that the Faculty of Sexual & Reproductive Healthcare (FSRH) is the standard-setting organisation for family planning and sexual health in United Kingdom (2104), as suggested by Dr Sokal.
2) I corrected the four grammatical errors noted by Dr Li and Dr Al Hussein Alawamlh. Table 1. Recommendations for exposing and occluding the vas deferens from practice guidelines on vasectomy.

EAU 9
The no-scalpel vasectomy technique of isolation of the vas deferens is associated with fewer early complications, such as infections, haematomas, and less postoperative pain. combining cautery of the mucosa of the vas with either electroor thermal-cautery, preferably combined with FI, is associated with the lowest risk of occlusion failure (<1%) 10,11 .
National standards and practices National standards and practices in targeted low-resource countries are described in Table 2 (Table 2).

Discussion
Creating and sustaining successful vasectomy programs in lowresource countries is challenging. Demand for vasectomy, access to services, and enabling environment must all be mutually reinforced 13 . Skillful vasectomy providers performing best practice surgical techniques is an essential component contributing to the success of vasectomy programs in countries where acceptance of vasectomy is low, follow-up of patients for complications is difficult, and access to post-vasectomy semen analysis to confirm success (or failure) of the procedure is not available.
On one hand, as recommended in the evidence-based vasectomy guidelines, NSV is uniformly adopted in the selected low-resource countries for isolating the vas deferens, minimizing the risk of bleeding and infection. On the other hand, cautery, which is recommended for occluding the vas in the guidelines, is seldom encountered in the targeted countries. In these countries, the most common standard for occluding the vas is LE+FI.
Although no vasectomy occlusion technique has been shown to be superior in terms of contraceptive effectiveness in comparative trials 9 , research evidence support the adoption of cautery over LE+FI for occluding the vas in low-resource settings 4,5,30 . Occlusion failure risks of 2.1% 31 2.5% 32 , 2.6% 33 , 5.9% 2 and 7.6% 34 have been reported for the LE+FI technique; these are much higher than the higher acceptable risk of occlusion failure of vasectomy, which is 1% 10 . In addition, even if FI is recommended to be combined with LE to decrease failure rate, it may not be commonly performed. In 2004, it was estimated that more than 95%, 97%, and 99% of vasectomies were done with simple LE without FI in India, Nepal, and Bangladesh despite country standards 35 . If no FI is added to LE, the occlusive failure risk is even higher and contraceptive failure may parallel occlusion failure. In a cohort of 1263 men from rural Nepal who had a vasectomy mostly performed by simple LE, 2.3% still had 500,000 sperm/ml or more in their semen 1 to 3 years after the procedure and the pregnancy rate reported was 4.2% after 3 years 17 . Finally, modelling the cost per couple-years of protection of LE, LE+FI, cautery, and cautery + FI in India, Kenya, and Mexico showed that cautery-based techniques are the most cost-effective methods 36 .
This study has two main limitations. First, the size of this convenience sample of eight countries is small. They were purposely chosen however to illustrate the situation in large and small vasectomy programs located on three continents. Second, some of the documents reviewed may be outdated. It is very only recently that Profamilia in Colombia updated their standards to include cautery combined with FI as the preferred occlusion technique of the vas 26 . To the author's knowledge, Haiti, Nepal, and Mexico are currently updating their male sterilization norms and standards. A future assessment of the norms and standards Table 2. National standards and practices for exposing and occluding the vas deferens in selected lowresource countries. Countries with large vasectomy programs are in italics. Despite the fact that vasectomies had significant potential for male family planning and population control in these countries, the question was whether vasectomies were utilized appropriately in these low resource countries, and whether vasectomies may reduce the need for the more risky and expensive female tubal ligations.

Vas isolation Vas occlusion Classic NSV LE LE+FI Cautery
In the 4 advanced countries, the practice guidelines were evidence-based for the most part. They indicated that the access to the vas should be minimally invasive which means: 1) a skin opening of < 10mm, 2) minimal dissection of the vas and peri vasal tissues, and 3) no skin sutures. With this approach, there was high quality evidence for a lower risk of surgical complications, bleeding and hematomas. In addition, these guidelines suggested that occlusion of the vas was best accomplished with cautery of the mucosa within the vas lumen and the use of fascial interposition to cover the ends of the cut vas. With this combination, the results yielded the lowest failure rate of <1%.
In contrast, it was interesting to note that only 6 of 8 of these low resource countries used a thermal cautery on a routine basis, and the use of fascial interposition was inconsistent. Most of these countries used excision and ligations of the cut ends of the vasa without fascial interposition, but this combination had a failure rate of 8-15%. When the cost/couple years of protection was computed, it indicated that cautery-based vasectomy techniques were the most cost-effective methods for family planning (Seamans and Harner-Jay, 2007 ). Therefore, it seems that all vasectomies should probably include mucosa 1 Gates Open Research © 2019 Sokal D. This is an open access peer review report distributed under the terms of the Creative Commons , which permits unrestricted use, distribution, and reproduction in any medium, provided the original Attribution Licence work is properly cited.

David Sokal
Male Contraception Initiative, Durham, NC, USA

General:
This is a very useful paper, and has implications for national vasectomy authorities, and for the World Health Organization, and for other organizations who wish to facilitate the use of best practices for vasectomy procedures. Support and training activities for vasectomy services deserve more attention.
Editorial comments: For clarity, please improve formatting and content of tables, specifically: Table 1: Put and in bold, and/or better separate these categories in some "Vas isolation" "Vas occlusion" other way(s). Also, what and where is FSRH? Google tells me that it is a UK standards body. That should be noted. Table 2: Italics is not sufficient to clearly identify the large and small programs, and ordering the countries by region seems less useful than ordering them by large and small, or put the large programs in bold?
Chair of the Board at the Male Contraceptive Initiative (MCI), Durham, NC, USA. This is an unpaid volunteer position. This review reflects my personal views, and not those of MCI.

Is the work clearly and accurately presented and does it cite the current literature? Yes
Is the study design appropriate and is the work technically sound? Yes

Are sufficient details of methods and analysis provided to allow replication by others? Yes
If applicable, is the statistical analysis and its interpretation appropriate?

Not applicable
Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes I worked with Michel Labrecque on several studies about 10 to 15 years ago and Competing Interests: