Safety and efficacy of a novel disposable circumcision device: a pilot randomized controlled clinical trial at 2 centers

Abstract

Background: We evaluated the safety and efficacy of a novel disposable male circumcision (MC) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co., Ltd.

Material and methods: Adult male patients (n=120; mean age, 26.6 years) with redundant foreskin and/or phimosis were included in a randomized, multicenter pilot clinical trial from October 2011 to February 2012. Patients were divided into 2 groups and subjected to MC with a novel disposable device (Device Group) (n=60) or to conventional dissection technique (CDT) (Control Group) (n=60). Intraoperative bleeding, surgery duration, pain, healing, and satisfaction with penis appearance were assessed. Adverse events (AEs) were noted.

Results: Intraoperative bleeding volume [3.5 ± 2.7 (15-35) ml vs. 13.1 ± 6.1 (4-25) ml] and mean surgical time [7.6 ± 4.5 (2-23) min vs. 23.6 ± 4.4 (15-35) min] in the Device Group were significantly less than in the Control Group (P<0.01). No AEs were observed in either group. There were no significant differences in postoperative pain, healing, or satisfaction with penis appearance between groups (P>0.05).

Conclusions: This novel disposable circumcision device produced satisfactory preliminary adult MC results compared with CDT treatments. This device may be broadly used in men, such as those with phimosis, who are ineligible for CDT.

Figure 1

Image of the device with labeled parts.

Figure 2

Surgical procedure using the novel, disposable circumcision device. (A) Placement of the inner rod on the glans penis and lifting of foreskin with vascular clamps; (B) fixation of the foreskin onto the outer pole; (C) control knob insertion into the free end of the outer pole and inner rod fixation with proper positioning of the control handle; (D) stabilization of the outer pole (left hand) and adjustment of control knobs (right hand), resulting redundant foreskin removal and staple closure simultaneously; and (E) counter-clockwise control knob rotation to remove the inner rod and the outer pole.

Figure 3

Wound healing following MC with the disposable circumcision device. (A) Wound after staple suture placement; (B) wound appearance after some staples were dislodged; (C) wound appearance after all staples spontaneously dislodged; (D) wound appearance with conventional sutures; and (E) wound appearance after suture removal.