PMID- 30520424 OWN - NLM STAT- MEDLINE DCOM- 20200518 LR - 20200518 IS - 1745-7262 (Electronic) IS - 1008-682X (Print) IS - 1008-682X (Linking) VI - 21 IP - 4 DP - 2019 Jul-Aug TI - Simplifying the ShangRing technique for circumcision in boys and men: use of the no-flip technique with randomization to removal at 7 days versus spontaneous detachment. PG - 324-331 LID - 10.4103/aja.aja_91_18 [doi] AB - 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. FAU - Barone, Mark A AU - Barone MA AD - EngenderHealth, Washington, DC 20004, USA. FAU - Li, Philip S AU - Li PS AD - Center for Male Reproductive Medicine and Surgery, Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY 10065, USA. FAU - Lee, Richard K AU - Lee RK AD - Center for Male Reproductive Medicine and Surgery, Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY 10065, USA. FAU - Ouma, Daniel AU - Ouma D AD - EngenderHealth, Nairobi 00100, Kenya. FAU - Oundo, Millicent AU - Oundo M AD - EngenderHealth, Nairobi 00100, Kenya. FAU - Barasa, Mukhaye AU - Barasa M AD - Bon Sante Consulting, Nairobi 00100, Kenya. FAU - Oketch, Jairus AU - Oketch J AD - Homa Bay County Teaching and Referral Hospital, Homa Bay 40300, Kenya. FAU - Otiende, Patrick AU - Otiende P AD - Homa Bay County Teaching and Referral Hospital, Homa Bay 40300, Kenya. FAU - Nyangweso, Nixon AU - Nyangweso N AD - Homa Bay County Teaching and Referral Hospital, Homa Bay 40300, Kenya. FAU - Maina, Mary AU - Maina M AD - Vipingo Health Centre, Vipingo 80119, Kenya. FAU - Kiswi, Nicholas AU - Kiswi N AD - Vipingo Health Centre, Vipingo 80119, Kenya. FAU - Chirchir, Betty AU - Chirchir B AD - Bon Sante Consulting, Nairobi 00100, Kenya. FAU - Goldstein, Marc AU - Goldstein M AD - Center for Male Reproductive Medicine and Surgery, Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY 10065, USA. FAU - Awori, Quentin D AU - Awori QD AD - EngenderHealth, Nairobi 00100, Kenya. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - China TA - Asian J Androl JT - Asian journal of andrology JID - 100942132 SB - IM CIN - Asian J Androl. 2019 Jul-Aug;21(4):423-424. PMID: 31115361 MH - Adolescent MH - Adult MH - Child MH - Circumcision, Male/*methods MH - Humans MH - Kenya MH - Male MH - Middle Aged MH - Patient Satisfaction MH - Treatment Outcome MH - Wound Healing MH - Young Adult PMC - PMC6628734 OTO - NOTNLM OT - HIV prevention OT - ShangRing OT - male circumcision device OT - no-flip technique OT - voluntary medical male circumcision EDAT- 2018/12/07 06:00 MHDA- 2020/05/19 06:00 PMCR- 2019/07/01 CRDT- 2018/12/07 06:00 PHST- 2018/12/07 06:00 [pubmed] PHST- 2020/05/19 06:00 [medline] PHST- 2018/12/07 06:00 [entrez] PHST- 2019/07/01 00:00 [pmc-release] AID - 246732 [pii] AID - AJA-21-324 [pii] AID - 10.4103/aja.aja_91_18 [doi] PST - ppublish SO - Asian J Androl. 2019 Jul-Aug;21(4):324-331. doi: 10.4103/aja.aja_91_18.