title: 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.
  
  
  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.
authors.affiliation: Department of Urology, Jiangxi Provincial People's Hospital, Nanchang, China (mainland).
authors.forename: Jingen
authors.initials: J
authors.lastname: Wang
authors.affiliation: Yongfeng Traditional Chinese Medicine Hospital, Yongfeng, China (mainland).
authors.forename: Yongfei
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: Department of Urology, Affiliated Hospital of Jiangxi College of Traditional Chinese Medicine, Nanchang, China (mainland).
authors.forename: Shuxia
authors.initials: S
authors.lastname: Xia
authors.affiliation: Department of Urology, Jiangxi Provincial People's Hospital, Nanchang, China (mainland).
authors.forename: Zunwei
authors.initials: Z
authors.lastname: Zhu
authors.affiliation: Department of Urology, Jiangxi Provincial People's Hospital, Nanchang, China (mainland).
authors.forename: Linghua
authors.initials: L
authors.lastname: Jia
authors.affiliation: Yongfeng Traditional Chinese Medicine Hospital, Yongfeng, China (mainland).
authors.forename: Yong
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Institution of Clinical Trial, Jiangxi Provincial People's Hospital, Nanchang, China (mainland).
authors.forename: Min
authors.initials: M
authors.lastname: Jiang
mesh_terms: D000328:Adult; D016063:Blood Loss, Surgical; D002944:Circumcision, Male / Q000009:adverse effects* / Q000295:instrumentation*; D003710:Demography; D004209:Disposable Equipment; D006801:Humans; D008297:Male; D061646:Operative Time; D010149:Postoperative Pain / Q000209:etiology; D017060:Patient Satisfaction; D010865:Pilot Projects; D011182:Postoperative Care; D013537:Sutures; D016896:Treatment Outcome; D055986:Vital Signs; D014945:Wound Healing