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Sources of Funding: The Bill & Melinda Gates Foundation (Global Health Grant Number OPP1084493) to EngenderHealth and Weill Cornell Medicine.

Introduction

Male circumcision (MC) reduces the risk of HIV and other STIs. ShangRing (SR) obtained WHO-prequalification in 2015. Previous studies have indicated that SR MC provides a safe, simple, quick, and minimally invasive approach to MC. In this study, we evaluated an innovative no-flip SR technique which is purported to be faster, simpler, and equally safe in comparison with the standard SR technique.

Methods

The no-flip technique involves inserting the inner ring of the SR under the foreskin followed by securely clamping the outer ring, providing hemostatic occlusion. The foreskin distal to the device is then excised. In this two-center RCT, the SR device was either removed at a 7-day follow-up or allowed to spontaneously detach. Each group was further divided into two sub-groups; 10-15 years and >15 years of age. Data on pain scores, adverse events (AEs), time to complete wound healing, and overall participant experience were collected.

Results

Of the 230 participants circumcised at the two study sites, 114 were allocated to the 7-day removal group, and 116 to the spontaneous detachment group. All participants were eligible for SR MC without the limitation of phimosis and adhesions. Pain 20 minutes postoperatively was similar in both groups (median score of 3). 8.4% of participants from ring removal group required additional analgesia at the time of ring removal vs. 2.8% in spontaneous group during the postoperative period (p=0.08). 27.6% of participants in the spontaneous detachment group requested device removal due to pain or discomfort. No AEs were severe. Moderate AEs were noted in 5.3% in the ring removal group vs. 1.7% in the spontaneous detachment group (p=0.14). Wound healing on day-42 was comparable, 90% of participants in the spontaneous detachment group showed healing vs. 78% of ring removal participants (p=0.57) (Figure 1). 97.7% of all participants were satisfied with the healed cosmetic appearance, and 99.5% were willing to recommend SR MC to others.

Conclusions

The no-flip SR technique was safe and effective; spontaneous detachment was generally acceptable to participants, allowing for comparable pain scores, wound healing, AE rates as well as equivalent safety compared to planned ring removal.

Funding

The Bill & Melinda Gates Foundation (Global Health Grant Number OPP1084493) to EngenderHealth and Weill Cornell Medicine.