Fascial Interposition Research Articles

Termination of a randomized controlled trial of two vasectomy techniques

Family Health International (FHI) and EngenderHealth conducted a multicenter, randomized controlled trial to evaluate a fascial interposition (FI) component of a vas occlusion procedure for male sterilization. A data monitoring committee (DMC) was established to provide independent review of the interim report. The DMC met to review the interim report after enrollment of 552 men. As planned, an estimate of the hazard ratio (HR) for successful vasectomy for the FI group versus the no-FI group controlling for age of the participant and level of experience of the surgeon was obtained for the interim report using Cox's proportional hazards regression. The main analysis comparing time to vasectomy success, defined as two consecutive azoospermic semen samples, was highly significant and met the prespecified level for stopping enrollment (HR=1.54, p<0.01). However, a troublesome age by vasectomy technique interaction became apparent in the analysis. FI was clearly beneficial for younger males. However, the trend for older men was not as clear. The DMC recommended continuing the trial to better study this interaction and obtain more data to clarify the effect of FI for older men. After consulting further with the DMC, the study statisticians presented the interim report to senior management at FHI. A meeting between FHI senior management and the DMC followed. After much deliberation, trial enrollment was terminated. Follow-up of participants already enrolled in the study continued as planned. This paper presents the issues involved in the decision to terminate the study.

Effectiveness and Complications Associated With 2 Vasectomy Occlusion Techniques

We compared the effectiveness and complications associated with 2 common vasectomy occlusion techniques, namely clipping and excision of a small vas segment and thermal cautery with fascial interposition and an open testicular end. We retrospectively reviewed the computerized records of 3,761 men who underwent initial vasectomy at a single university hospital family planning clinic and at 2 private clinics in the Quebec City, Canada area, including concurrent and historical controls. All procedures were performed by 1 surgeon, who used the scalpel-free technique to expose the vas. The risk of vas occlusion failure in men with at least 1 semen analysis was much greater in the clipping and excision group than in the cautery, interposition and open testicular end group (126 of 1,453 or 8.7% versus 3 of 1,165 or 0.3%, OR 37, 95% CI 12 to 116). Medical consultations for hematoma or infection were more frequent in the cautery group (28 of 1,721 cases or 1.6% versus 10 of 2,040 or 0.5%, OR 3.4, 95% CI 1.6 to 6.9). Consultations for noninfectious pain were similar for the 2 techniques (71 of 1,721 cases or 4.1% versus 72 of 2,040 or 3.5%, OR 1.2, 95% CI 0.8 to 1.6). Cautery and interposition with an open testicular end are much more effective than clipping and excision. The effectiveness and morbidity associated with the components of the cautery, interposition and open testicular end technique need further evaluation.

Clinical aspects of vasectomies performed in the United States in 1995

Objectives. Currently, no surveillance system collects data on the numbers and characteristics of vasectomies performed annually in the United States. This study provides nationwide data on the numbers of vasectomies and the use of no-scalpel vasectomy, various occlusion methods, fascial interposition, and protocols for analyzing semen after vasectomy. Methods. A retrospective mail survey (with telephone follow-up) was conducted of 1800 urology, family practice, and general surgery practices drawn from the American Medical Association’s Physician Master File and stratified by specialty and census region. Mail survey and telephone follow-up yielded an 88% response rate. Results. In 1995, approximately 494,000 vasectomies are estimated to have been performed by 15,800 physicians in the United States. Urologists performed 76% of all vasectomies, and nearly all (93%) urology practices performed vasectomies in 1995. Nearly one third (29%) of vasectomies in 1995 were no-scalpel vasectomies, and 37% of physicians performing no-scalpel vasectomies taught themselves the procedure. The most common occlusion method in 1995 (used for 38% of all vasectomies) was concurrent use of ligation and cautery. In 1995, slightly less than half (48%) of all physicians surveyed interposed the fascial sheath over one end of the vas when performing a vasectomy. Protocols for ensuring azoospermia varied: 56% of physicians required one postvasectomy semen specimen; 39% required two, and 5%, three or more. Conclusions. No-scalpel vasectomy, used by nearly one third of U.S. physicians, has become an accepted part of urologic care. Physicians’ variations in occlusion methods, use of fascial interposition, and postvasectomy protocols underscore the need for large scale, controlled, and statistically valid studies to determine the efficacy of occlusion methods and fascial interposition, as well as whether azoospermia is the only determination of a successful vasectomy.

Long Term Review of Fascial Replacement After Excision of the Carpal Lunate Bone

Excision of the carpal lunate bone in Kienbock's avascular necrosis gives relief of pain. To maintain grip strength, increase range of motion, and prevent carpal collapse or shifting, this space has been filled with various materials. Forty-three patients received fascial interposition replacement, and the experience and results of 10 patients observed for 10 years or more (range, 10-34) are presented. Pain was relieved. Range of motion was increased. Carpal collapse did not occur. All patients use their hand in an unrestricted, stressful activity. The result of an operation during an extended period is documented.

Post-traumatic contracture of the elbow. Operative treatment, including distraction arthroplasty.

Twenty-six consecutive patients who had post-traumatic contracture of the elbow were treated by operative release alone or by release and distraction arthroplasty, with or without fascial interposition. The type of operative procedure was determined by whether the factors limiting motion were purely extra-articular (extrinsic) or whether they included intra-articular (intrinsic) elements as well. The mean preoperative arc of total motion was 30 degrees (from 63 to 93 degrees of flexion). At follow-up examination, twenty-two to ninety-four months post-operatively, of twenty-five patients, the mean arc of total motion was 96 degrees (from 30 to 126 degrees). There were eight complications in seven (27 per cent) of the patients. Of these, four (avulsion of the triceps tendon, deep infection, and two ulnar-nerve paresthesias) were managed by subsequent operative treatment. The other four complications included drainage from a pin site, which resolved after removal of the pin: a three by two-centimeter skin slough, which spontaneously epithelialized; aseptic resorption of the distal end of the humerus and proximal end of the ulna, which stopped after immobilization and subsequent bracing of the elbow but resulted in moderate instability; and ulnar-nerve paresthesia, which was not operatively treated and persisted. Twenty-four (96 per cent) of the twenty-five patients who were followed for twenty-two months or more were satisfied with the results of the procedure because of the improved facility in carrying out activities of daily living. No patient had increased pain, but two had moderate instability. It was concluded that the results of distraction arthroplasty can be gratifying, but the technique is demanding and the rate of complications is high.

The Lurking Sperm: Vasectomy Failures-Reply

In Reply. — I appreciate the letters in response to my editorial on vasectomy. Scientific progress is made by discussion and the exchange of knowledge. Dr Alderman's results have provided us with a valuable yardstick with which to measure the most popular method of vasectomy, and he has done us a favor. The fact that I feel that there is a better way does not diminish the personal regard that I have for this fine man. I cannot say why others have not published their experiences with the fulguration, fascial interposition method, but I have many friends who have had excellent results with it. Any failures could only result from improperly carrying out the operation, such as incompletely covering the vas end with fascia. Dr Barnhouse, in leaving the testicular end of the vas untouched, brings up a point that I had avoided when I wrote that at least one