【摘 要】
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Objective: Safety and efficacy of a disposable male circumcision (MC) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co., Ltd was evaluated.Methods: Adult male patients (n =120) betwe
【机 构】
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Institutions of clinical trial, Jiangxi Provincial People's Hospital, Nanchang 330006,China
【出 处】
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中国药理学会药物临床试验专业委员会首届学术研讨会
论文部分内容阅读
Objective: Safety and efficacy of a disposable male circumcision (MC) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co., Ltd was evaluated.Methods: Adult male patients (n =120) between the ages of 17 and 67 years (mean 26.6 years)with redundant foreskin and/or phimosis were included in a randomized, multicenter pilot clinical trial over the course of 2 weeks from October 20, 2011 to February 12, 2012.Patients were randomly divided into two equal groups and subjected to either MC with a novel disposable device (Device group) (n =60) or conventional dissection technique (CDT) (control group) (n =60).Intraoperative bleeding and surgery duration were assessed.Pain, healing, and satisfaction with penis appearance were assessed pre-surgically (day 0) and at postsurgical days 1, 3, 7, and 14.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.23.64-4.4 (15-35) min] in the Device group were significantly less than those observed in the control group (P < 0.01).No AEs, including postoperative wound bleeding or infection, were observed in either group.Good results for postoperative pain, healing, and satisfaction were reported in both groups without significant difference between groups (P > 0.05).Conclusion: For adult MC, this novel disposable circumcision device produced satisfactory preliminary results compared with CDT treatments.Its simplicity may reduce surgical times and blood loss.This device may be broadly applicable men, such as those with phimosis, ineligible for CDT.
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