Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes

Feldblum, Paul J.; Zulu, Robert; Linyama, David; Long, Sarah; Nonde, Thikazi Jere; Lai, Jaim Jou; Kashitala, Joshua; Veena, V. S.; Kasonde, Prisca

doi:10.1097/qai.0000000000001015

Cited by 5 publications

(4 citation statements)

References 17 publications

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“…All were moderate, occurred during follow-up, were considered definitely related to the circumcision, and resolved with conservative management and without sequelae. Among participants with the no-flip technique and removal at 7 days, 5.3% (6/114; 95% CI: 1.2%–9.4%) had an AE, which was not higher, using a one-sided test, than the 3% from historical data with the flip technique ( P = 0.07) 17181920213637. Following circumcision with the no-flip technique and spontaneous detachment, 1.7% (2/116; 95% CI: 0–4.1%) of participants had an AE, also not different from previously published studies ( P = 0.79).…”

Section: Resultsmentioning

confidence: 87%

“…The no-flip technique simplifies the procedure since eversion of the foreskin and making 8–10 small slits needed in the tissue that remains after the foreskin is excised is unnecessary. Results from a study in Zambia showed that reducing the number of adult device sizes in half (from 14 to 7) by eliminating every other size did not reduce the safety, effectiveness, or acceptability of ShangRing VMMC 37. Having to stock fewer sizes would simplify supply chain logistics and inventory issues.…”

Section: Discussionmentioning

confidence: 99%

“…For our primary objective, we examined data from previous ShangRing studies in Africa that used the flip technique with removal at 7 days. The range of AE rates was 0.8%–7.6% 17181920213637. We used 3% to represent the baseline AE rate for the flip technique.…”

Section: Participants and Methodsmentioning

confidence: 99%

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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

Barone

Lee

et al. 2019

Asian J Androl

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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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