Abstract
OBJECTIVE: To conduct a proof-of-concept study to determine the potential utility of a novel, adjustable single-visit, disposable device to facilitate rapid adult circumcision. DESIGN: Prospective pilot trial of a novel surgical device. SETTING: Tertiary care Veterans Administration medical center. PATIENT(S): Five adult males. INTERVENTION(S): Circumcisions performed by junior trainees using an adjustable, single-size surgical-assist device constructed by the University of Washington Applied Physics Laboratory. MAIN OUTCOME MEASURE(S): The attending surgeon and trainees completed standardized forms after each procedure to assess technical problems and ease of use. Follow-up visits were scheduled to evaluate adverse events, postoperative pain, cosmetic outcomes, and participant satisfaction at 3, 8, 30, and 90 days postoperatively. RESULT(S): The average operative time was 16.4 minutes. All cases were performed with local anesthesia, and no case required electrocautery or conversion to standard surgery. At the postoperative day 3 visit, all subjects were happy with their results and would recommend the procedure to another patient. One participant had a minor wound separation noted at the 30-day visit that resolved during follow-up. There were no wound infections, hematomas, or other adverse events. CONCLUSION(S): This proof-of-study suggests that the Simple Circumcision Device may facilitate delivery of safe adult male circumcision services.