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

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.

No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya

“…In their reports, the WHO had indicated that Prepex circumcision was not feasible with foreskin conditions, including phimosis, thus limiting its use in a good proportion of adolescents [19,21,22]. The time needed to perform the procedure in 10 to 12 year old boys was found to be similar to that of the rest of the cohort in the respective trials [11,12]. This was also similar to the duration of circumcision with the standard ShangRing technique, which has been reported in previous trials to be significantly less than conventional circumcision techniques [9,10,20].…”

“…We performed a sub-analysis of outcomes in 10 to 12 year old males from results of two randomized controlled clinical trials of no-flip ShangRing circumcision in men and boys aged 10 to 54 years [11,12]. Both trials were conducted at two sites; the Homa Bay County Teaching and Referral Hospital, Homa Bay, Kenya and Vipingo Health Center in Kilifi County, Kenya.…”

“…1% lidocaine (Fig 3). The 2:1 randomization scheme was used since all participants in the first trial had undergone injectable anesthesia and pain scores were reported for the entire cohort [11]; therefore, it was unnecessary to have a 1:1 randomization. However, given the subjectivity when reporting pain scores, it was critical to randomize participants in this trial.…”

“…For the first trial, the sample size of each group provided 80% power to detect an increase of 7% of adverse events with the use of no-flip ShangRing circumcision with either spontaneous device detachment or planned removal 7 days post-operatively, using a onesided test and alpha of 0.05. This is based on historic adverse event data of previous ShangRing studies that have utilized the standard flip technique with planned device removal 7 days postcircumcision [11]. In the second trial, the sample size provided 100% power to detect a mean difference of 1 on the 0-10 pain scale with a standard deviation of 1.8, using a two-sided test at alpha of 0.05.…”

“…Recently, results from men and boys aged 10 to 54 years who were enrolled in two randomized clinical trials of no-flip ShangRing circumcision in Kenya have been published [11,12]. In addition to assessing the safety, acceptability, and efficacy of the ShangRing, the first trial aimed to assess spontaneous device detachment as part of postoperative care management, and the second trial sought to evaluate the use of topical anesthesia with the procedure.…”