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Abstract

Volume 21, Issue 4 (July 2019) 21, 324–331; 10.4103/aja.aja_91_18

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

Mark A Barone1, Philip S Li2, Richard K Lee2, Daniel Ouma3, Millicent Oundo3, Mukhaye Barasa4, Jairus Oketch5, Patrick Otiende5, Nixon Nyangweso5, Mary Maina6, Nicholas Kiswi6, Betty Chirchir4, Marc Goldstein2, Quentin D Awori3

1 EngenderHealth, Washington, DC 20004, USA
2 Center for Male Reproductive Medicine and Surgery, Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY 10065, USA
3 EngenderHealth, Nairobi 00100, Kenya
4 Bon Santé Consulting, Nairobi 00100, Kenya
5 Homa Bay County Teaching and Referral Hospital, Homa Bay 40300, Kenya
6 Vipingo Health Centre, Vipingo 80119, Kenya

Correspondence: Dr. MA Barone (mbarone@popcouncil.org)

30-Nov-2018

Abstract

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.

Keywords: HIV prevention; male circumcision device; no-flip technique; ShangRing; voluntary medical male circumcision

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