To assess safety of the no-flip ShangRing male circumcision technique and to determine clinical course and safety of spontaneous detachme nt (i.e., allowing the device to fall off), we con ducted a case series of no-f...To assess safety of the no-flip ShangRing male circumcision technique and to determine clinical course and safety of spontaneous detachme nt (i.e., allowing the device to fall off), we con ducted 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 sec on dary outcome was clinical course and safety of spontan eous 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 spontan eous group had an AE;with no d iff ere nces 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 participants1 request, due to pain or discomfort. There was no d iff ere nee 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.展开更多
文摘To assess safety of the no-flip ShangRing male circumcision technique and to determine clinical course and safety of spontaneous detachme nt (i.e., allowing the device to fall off), we con ducted 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 sec on dary outcome was clinical course and safety of spontan eous 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 spontan eous group had an AE;with no d iff ere nces 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 participants1 request, due to pain or discomfort. There was no d iff ere nee 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.
