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
It has been 10 years since we published the first report describing use of the ShangRing for circumcision in boys and men. That report, by Peng et al.{ from China, showed that the device was safe and that ShangRing ci...It has been 10 years since we published the first report describing use of the ShangRing for circumcision in boys and men. That report, by Peng et al.{ from China, showed that the device was safe and that ShangRing circumcision was quicker than with conventional surgical techniques commonly used. The ShangRing, pictured in Figure 1, isa novel collar clamp circumcision device that was invented by Mu Jian-Zhong Shang in China in the early 2000s to reduce potential surgical complications following male circumcision. Based on its successful use in 2006, Mr. Shang started SNNDA Medical Company to produce and distribute the ShangRing. The device has two parts consisting of an inner ring and an outer ring. The foreskin is sandwiched between the two rings, ensuring hemostasis without the need for suturing, which greatly simplifies the circumcision. The device is typically removed by a clinician 7-10 days later.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.
文摘It has been 10 years since we published the first report describing use of the ShangRing for circumcision in boys and men. That report, by Peng et al.{ from China, showed that the device was safe and that ShangRing circumcision was quicker than with conventional surgical techniques commonly used. The ShangRing, pictured in Figure 1, isa novel collar clamp circumcision device that was invented by Mu Jian-Zhong Shang in China in the early 2000s to reduce potential surgical complications following male circumcision. Based on its successful use in 2006, Mr. Shang started SNNDA Medical Company to produce and distribute the ShangRing. The device has two parts consisting of an inner ring and an outer ring. The foreskin is sandwiched between the two rings, ensuring hemostasis without the need for suturing, which greatly simplifies the circumcision. The device is typically removed by a clinician 7-10 days later.