Clinical investigation of a novel surgical device for circumcision.

Abstract

We investigated the performance of a novel device for adult circumcision, that is the circular cutter with stapled anastomosis for circumcision. A total of 62 men with a mean ± SD age of 28 ± 8 years were enrolled from June to September 2012 to undergo circumcision using the circular cutter with stapled anastomosis. The device used 18 staples for anastomosis, which fall out during the recovery course, as designed. Patients were followed at day 3, and weeks 1, 2, 4 and 12 after the procedure. Outcome measures were evaluated, including patient safety, procedural time, patient satisfaction and complication rate. Average procedural time needed to use the device was 7.7 ± 2.6 minutes. Patients returned to full physical activity on postoperative day 3. The overall complication rate was 4.8%, including 1 case of intraoperative bleeding due to operator inexperience and 2 of a delay in staples falling out. No patient experienced wound infection or excessive foreskin excision. No incision site edema was observed beyond postoperative day 7. All enrolled patients were satisfied with the postoperative penile cosmesis. The circular cutter with stapled anastomosis for circumcision is a 1-step device that can achieve excellent postoperative results with minimal procedural time. Therefore, it has the potential to enable the performance of circumcision as a rapid turnover bedside procedure.