Scalpel versus no scalpel incision for vasectomy
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The objective of this review is to compare the effectiveness, safety, acceptability and costs of scalpel versus no‐scalpel incision for vasectomy. The review does not cover other vasectomy techniques, such as vas occlusion techniques, as they will be covered in the planned review titled "Vasectomy Techniques for Male Sterilization."
Background
Although vasectomy is a highly effective and relatively low‐cost permanent family planning method, [PIP 1992] the degree to which vasectomy has been adopted varies widely around the world due to a range of factors, including societal attitudes, the availability and accessibility of services, and acceptability of the procedure. [Ringheim 1993] One of the influences on the acceptability of vasectomy is the safety of the procedure. While adverse events following vasectomy are relatively uncommon, [PIP 1992] men may experience bleeding, bruising, infection, acute and chronic pain after the procedure. [RCOG 1999] The method of incision used to approach the vas can affect the occurrence of vasectomy‐related adverse events. Currently, the two most common surgical techniques for approaching the vas during vasectomy are the incisional method and the no‐scalpel technique. [Schwingl 2000] Whereas the conventional incisional technique involves the use of a scalpel to make one or two incisions (each 1‐2 cm in length), the no‐scalpel technique uses a sharp, pointed, forceps‐like instrument to puncture the scrotum. The no‐scalpel technique, which was developed in China, aims to reduce adverse events, in particular, bleeding, bruising and pain. This method generally requires more training and skill than the conventional incisional method. [RCOG 1999]
Evaluation of the relative effectiveness, safety and acceptability of these two approaches to the vas during vasectomy is vital to inform the decision making of both health service providers and clients. Ideally, choice of incision method for vasectomy should be based on the best available evidence from randomized controlled trials. One trial has been identified that compares the incisional method with the no‐scalpel technique. [Sokal 1999]
Objectives
The objective of this review is to compare the effectiveness, safety, acceptability and costs of scalpel versus no‐scalpel incision for vasectomy. The review does not cover other vasectomy techniques, such as vas occlusion techniques, as they will be covered in the planned review titled "Vasectomy Techniques for Male Sterilization."
Methods
Criteria for considering studies for this review
Types of studies
Only randomized controlled trials will be included in this review. No language restrictions will be placed on the reporting of the trials.
Types of participants
Men of reproductive age undergoing vasectomy for sterilization.
Types of interventions
We will examine two techniques for the approach to the vas for vasectomy: the incisional method and the no‐scalpel method.
Types of outcome measures
We will focus on clinically relevant outcome measures. The primary outcome, post‐vasectomy adverse events, and the secondary outcomes are as follows:
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Adverse events including, but not limited to, haematoma, scrotal abscess, wound infection, local pain and tenderness, reaction to suture material, bleeding, epididymo‐orchitis, chronic testicular/scrotal pain, congestive epidydymitis and vasovagal episodes
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Operating time
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Time to resumption of intercourse
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Azoospermia rates at post vasectomy follow‐up visits
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Time to azoospermia
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Incidence of recanalization
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Incidence of repeat vasectomy
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Cost analysis
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Consumer acceptability measures
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Provider acceptability measures
Search methods for identification of studies
We will obtain relevant randomized controlled trials from a search of publications describing vas occlusion techniques for male sterilization. We will conduct computerized searches of MEDLINE using PubMed, EMBASE, POPLINE, LILACS and the Cochrane Central Register of Controlled Trials (CENTRAL) using the following search strategies:
PUBMED
(((sterilization, sexual AND (male OR men)) OR vasectomy)) AND ((clinical trials OR random allocation OR double‐blind method OR single‐blind method OR research design OR comparative study OR evaluation studies OR follow‐up studies OR prospective studies OR intervention studies OR evaluation studies OR randomized controlled trial[pt] OR controlled clinical trial[pt] OR clinical trial[pt] OR ((singl* OR doubl* OR trip* OR trebl*) AMD (blind OR mask)) OR random OR latin square OR control* OR prospectiv* OR volunteer) NOT (animal NOT human))
POPLINE
(clinical trials / comparative studies) & ((vas occlusion / vas ligation / vasectomy / male sterilization) NOT vas reanastomosis)
EMBASE
((((vasectomy OR male(W)sterilization OR (vas AND excision) OR ((vas(w)irrigation) OR (fascial AND interposition) OR (suture ligature(w)vas) OR (vas AND irrigation) OR (open‐ended AND vas) OR (surgical(W)clips AND vas) OR (electrocautery AND vas) OR (chemical(W)occlusion AND vas)) AND ((method OR methods) OR technique OR techniques))) AND Human) NOT vasovasostomy
LILACS
((men OR male) AND (sterilization, sexual) OR esterilizacao sexual OR esterilizacion sexual)) OR vasectomy OR vasecomia
CCTR
vasectomy
We will search the reference lists from all identified studies as well as citations from key book and review articles for additional, previously unidentified trials. Furthermore, we will attempt to find unpublished randomized controlled trials through personal communication with experts.
Data collection and analysis
Study Identification
Two reviewers will assess the titles and abstracts from our literature search and will evaluate copies of all possibly relevant articles to determine eligibility. Any disagreements or discrepancies will be resolved by discussion or by consulting a third reviewer.
Methodological quality
We will assess the methodological quality of the eligible articles with reference to the Cochrane Reviewers Handbook 4.1, Section 6 (Clarke 2002). The assessment of the validity of studies will be focused on the method of randomizing the allocation sequence, the use and method of allocation concealment, the use and method of masking, and exclusion of participants after randomization.
Data Extraction
We will develop and field test a data collection form, as described in the Cochrane Reviewers Handbook 4.1, Section 7.1, (Clarke 2002) before examining the identified trials for possible inclusion. Two reviewers will independently collect the data on the abstraction forms. In addition to the outcomes measures, we will systematically extract data on the following variables: lost to follow‐up rates, type and location of health care setting (e.g., mobile/static unit and time available for the operation), surgeon experience level, age of the men, total number of men included and inclusion/exclusion criteria. Any disagreements or discrepancies will be resolved by discussion or by consulting a third reviewer. When necessary, we will contact the authors of the trials to obtain additional information. One reviewer will enter the abstracted data into the Cochrane Collaboration Review Manager software (RevMan 4.1). Correct entry of the data will be verified by at least one other reviewer.
Data Analysis
Using RevMan 4.1 we will calculate odds ratios with 95% confidence intervals for dichotomous variables and weighted mean difference with 95% confidence intervals for continuous variables. When possible, we will describe the method used by the investigators to assess objective outcomes. Pooling of data between identical comparisons of interventions will be considered if the outcome measure has been measured in a sufficiently similar manner, including timing. We will test for heterogeneity between pooled results using a standard chi squared test. In the presence of significant heterogeneity, we may also perform a sensitivity analysis based on the methodological quality of the trials. Meta‐analysis will be performed under a random effects model, using RevMan 4.1. Narrative summaries will be provided when neither dichotomous nor continuous outcome data compatible with RevMan 4.1 are available. If available, we will use intention‐to‐treat analysis; however, we will be limited to the analytic method used by the authors of the study.
