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

Abstract

BackgroundWe evaluated the safety and efficacy of a novel disposable male circumcision (MC) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co., Ltd.Material/MethodsAdult 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.ResultsIntraoperative 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).ConclusionsThis 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.

Phimosis in Adults: Narrative Review of the New Available Devices and the Standard Treatments

“…The guidelines for the management of lichen sclerosus, an autoimmune, inflammatory derma- Fourteen studies (45.2%) were classified as case-series [4,[16][17][18][19][20][21][22][23][24][25][26][27][28] and six studies (19.4%) were classified as case-comparative series, in both cases with a retrospective evaluation of the reported data [29][30][31][32][33][34]. Finally, eleven (35.5%) were prospective case-control studies [6,[35][36][37][38][39][40][41][42][43][44].…”

“…Wang J et al compared the results obtained in patients treated with sleeve circumcision or a technique using the Langhe device: no significant difference in postoperative pain, wound healing, or satisfaction were reported between the two groups for any day of follow-up (p > 0.05), reducing operative time and blood loss [40].…”

Phimosis in adults: narrative review of the current treatments

“…Fourteen studies (46,7%) were classified as case-series [4], [16][17][18][19][20][21][22][23][24][25][26][27][28] and 6 studies (20,0%) were classified as case-comparative series, in both cases with a retrospective evaluation of the reported data [29][30][31][32][33][34]. Finally, 10 (33,3 %) were prospective case-control studies [6], [35][36][37][38][39][40][41][42][43].…”

“…Wang J et al compared the results obtained in patients treated with sleeve circumcision or device technique using Langhe device: no significant difference in postoperative pain, wound healing, or satisfaction were reported between the 2 groups for any day of follow-up (P>0.05) reducing operative time and blood loss [40].…”

Commentary on "Disposable circumcision suture device: clinical effect and patient satisfaction"

“…In addition, Wang et al . 3 performed a randomized, multicenter pilot clinical trial to compare the DCSD circumcision method with conventional dissection methods, using 10–20 ml of 1% lidocaine injection per patient. However, they found no significant difference in postoperative pain between the groups at 1, 3, 7, and 14 days of follow-up ( P > 0.05).…”