V9-03: Randomized Clinical Trial of the No-Flip ShangRing Circumcision for Adolescents and Adults in Africa
Male circumcision (MC) provides a variety of medical benefits, including a 50-60% reduced risk of HIV transmission. The ShangRing is one of two WHO-prequalified MC devices and it comprises a key component of the scale-up of MC services in Africa. The No-Flip ShangRing circumcision technique represents a further simplification of this procedure. The objective of this study was to evaluate the outcomes of this technique in African adults and adolescents with regard to procedure duration, pain, adverse events, healing time, and patient satisfaction. Further, we sought to compare safety, healing rates and patient satisfaction after ring removal at 7 days versus spontaneous detachment.
We enrolled patients 10 years of age or older at two study sites in Kenya. All procedures were performed by physicians or nurses trained in the No-Flip ShangRing technique. Patients were randomized in 1:1 fashion to ring removal at 7 days versus spontaneous detachment. Outcomes were assessed weekly until 42 days or complete wound healing.
230 patients were enrolled in this study, age ranges 10 to 54. Over 80% of circumcisions were performed by nurses trained in the No-Flip technique. All patients (230/230) were suitable for ShangRing MC regardless of the presence of phimosis or adhesions. On subgroup analysis of patients 10-15 years of age versus >15 years, though more patients in the younger group required a dorsal slit and breaking down of adhesions prior to ring insertion, there was no difference in operative time and all circumcisions were successfully completed (Table 1). There was no difference in pain or adverse events between the age groups, and there was ≥97% patient satisfaction in both groups. Within the group randomized to spontaneous detachment, 72.4% of patients experienced detachment at median 14 days; 27.6% of patients requested ring removal due to pain or discomfort. There were no differences between spontaneous detachment and 7-day removal with regard to healing time, adverse events, or patient satisfaction.
The No-Flip ShangRing procedure is simple, safe, effective, and acceptable for use in patients 10 years of age or older. Spontaneous detachment is safe and effective, and has the potential to reduce the burden of service provision in resource-poor settings.
Funding: The Bill & Melinda Gates Foundation (Global Health Grant Number OPP1084493) to EngenderHealth and Weill Cornell Medicine