【摘 要】
：
To assess safety of the no-flip ShangRing male circumcision technique and to determine clinical course and safety of spontaneous detachment (i.e.,allowing the device to fall off),we conducted a case series of no-flip ShangRing circumcision combined with a
【机 构】
：
EngenderHealth, Washington, DC 20004, USA;The Population Council, New York, NY 10065, USA;Center for
论文部分内容阅读
To assess safety of the no-flip ShangRing male circumcision technique and to determine clinical course and safety of spontaneous detachment (i.e.,allowing the device to fall off),we conducted a case series of no-flip ShangRing circumcision combined with a randomized controlled trial of removal 7 days postcircumcision versus spontaneous detachment at two health facilities in Kenya.The primary outcome was the safety of the no-flip technique based on moderate and severe adverse events (AEs) during the procedure and through 42-day follow-up.A main secondary outcome was clinical course and safety of spontaneous detachment.Two hundred and thirty males 10 years and older underwent no-flip circumcision;114 randomized to 7-day removal and 116 to spontaneous detachment.All circumcisions were successfully completed.Overall 5.3％ (6/114) of participants in the 7-day group and 1.7％ (2/116) in the spontaneous group had an AE;with no differences when compared to the 3％ AE rate in historical data from African studies using the original flip technique (P =0.07 and P =0.79,respectively).Overall 72.4％ (84/116) of participants in the spontaneous group wore the ShangRing until it detached.Among the remaining (27.6％;32/116),the ring was removed,primarily at the participants\' request,due to pain or discomfort.There was no difference in AE rates (P =0.169),visit day declared healed (P =0.324),or satisfaction (P =0.371) between randomization groups.The median time to detachment was 14.0 (IQR:7-21,range:5-35) days.The no-flip technique and spontaneous detachment are safe,effective,and acceptable to boys and men 10 years and older.Phimosis and penile adhesions do not limit successful ShangRing circumcision with the no-flip technique.
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