Consider additional vasectomy technique
Consider additional vasectomy technique
Family planning providers who are practicing simple ligation-and-excision vasectomies should consider modifying their technique to include fascial interposition, according to preliminary research indicating such changes could improve effectiveness. Interim results from the research clinical trial, conducted by EngenderHealth in New York City and Family Health International (FHI) in Research Triangle Park, NC, were presented at the December 2001 annual meeting of the Washington, DC-based Association of Reproductive Health Professionals (ARHP).
Vasectomy is a surgical procedure in which the vasa deferentia (the tubes that carry sperm from the testes) are closed by ligation or other means. Fascial interposition calls for the sheath covering the vas to be pulled over one severed end and sewn shut to create a natural tissue barrier. Vasectomy is a very effective contraceptive method; Contraceptive Technology estimates the method has about a 0.1% probability of pregnancy in the first year.1
Preliminary results from the study, conducted in seven countries, indicate that use of fascial interposition leads to a more rapid decrease in sperm counts, which may improve the effectiveness of ligation and excision vasectomies. When fascial interposition was used along with ligation and excision of the vas, about 93% of men had reached a low sperm count (fewer than 100,000 sperm per milliliter of semen) by 22 weeks after surgery, compared to 81% of men without fascial interposition.2 Men who have not undergone vasectomy typically have between 20 million and 150 million sperm per milliliter of semen.
"Although we shy away from making recommendations for change in practice based on the results of one study, the results of this level 1 study, along with the data available in the literature, lead us to believe that we can recommend use of fascial interposition when vasectomy is done by ligation and excision," says Amy Pollack, MD, MPH, EngenderHealth president.
Take a closer look
While there are good data to support the use of no-scalpel vasectomy over conventional vasectomy,3 data demonstrating the superiority of any one occlusion method over any other have been lacking, Pollack comments. A variety of methods are used for occlusion of the vas, with ligation and excision the most commonly used method in low-resource settings, says David Sokal, MD, FHI associate medical director.
EngenderHealth and FHI conducted a pilot study of the ligation and excision method and found that relatively high concentrations of sperm appeared to persist for longer than expected, says Sokal.4 A larger study confirmed those results and led to the conduct of a randomized controlled trial, with its interim results presented at the December 2001 ARHP meeting.
"Two key findings from this study were that a) there was a prolonged risk of continued fertility that could only be explained by some degree of recanalization [reconnecting of the cut ends of the vas]; and b) that there was great variability in the onset of azoospermia both in terms of time and number of ejaculations following vasectomy," Pollack comments. "These data led us to believe that vasectomy by ligation and excision alone might not be as effective as had been thought."
What’s the next step?
While recruitment into the larger study was stopped in May 2001, researchers will be following up all men who already had a vasectomy according to the original schedule, says Pollack. Follow-up will continue until May 2002, she notes.
In light of the findings, EngenderHealth is updating its training materials to include the new information about the benefits of fascial interposition, as well as the technical information providers need in order to perform the fascial interposition procedure.
"In addition, we will be making sure that all our materials give adequate attention to the possibility — albeit small — that vasectomy can fail in the discussion of informed choice and consent," states Pollack.
Providers who are using a simple ligation and excision technique and don’t have good follow-up data, such as semen analyses, to show that their technique is successful, should consider incorporating fascial interposition into their technique, says Sokal.
Despite the study’s findings, it is important to remember that vasectomy remains a highly effective method of contraception and that it is difficult to make general statements about vasectomy failure because of the wide variety of occlusion methods used, says Pollack.
Some experts believe that cautery [burning the vas] may be the most effective vasectomy occlusion technique, with or without fascial interposition. However, using cautery requires special equipment that might not be practical in low-resource settings. FHI and EngenderHealth are planning studies to evaluate cautery techniques for use in such settings.
References
- Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology. 17th revised ed. New York: Ardent Media; 1998.
- EngenderHealth and Family Health International. Additional Vasectomy Techniques Recommended. Press release. Oct. 11, 2001.
- Sokal D, McMullen S, Gates D, et al. A comparative study of the no-scalpel approach and the standard incision approach to vasectomy in five countries. J Urology 1999; 162:1,621-1,625.
- Cortes M, Flick A, Barone MA, et al. Results of a pilot study of the time to azoospermia after vasectomy in Mexico City. Contraception 1997; 56:215-222.
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