Fertil Steril 2014 May 6;101(5):1266-70. Epub 2014 Mar 6.
Department of Urology, University of Washington Medical Center, Seattle, Washington; Veterans Administration Puget Sound Health Care System, Seattle, Washington.
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.