Abstract
BACKGROUND: The ShangRing is a disposable, collar clamp circumcision device pre-qualified for use in men and boys 13 years and above. It has been shown to be faster than conventional circumcision with comparable adverse event (AE) rates and high client satisfaction. Voluntary medical male circumcision (VMMC) has been shown to dramatically reduce the risk of HIV acquisition in males. However, the fear of pain during circumcision is an important barrier to uptake. Use of topical anesthesia thus presents an opportunity to address this. OBJECTIVES: We sought to evaluate the safety, effectiveness and acceptability of the use of topical anaesthesia with ShangRing circumcision of men and boys 10 years of age and above. METHODS: Participants were randomised 2:1 to receive topical or injectable anaesthesia. All participants underwent no-flip ShangRing circumcision. The primary outcome measure was pain. Secondary outcomes included ease of use of topical versus injectable anaesthesia, AEs and participant satisfaction. RESULTS: Compared to the topical group, participants in the injectable group reported significantly more pain on administration of the anesthesia and at approximately 20 minutes after the procedure. In the topical group, sufficient anaesthesia with topical cream was not achieved in 21 (9.3%) cases before the start of the procedure; in another 6 (2.6%), supplementary injectable anaesthesia was required as the circumcision was being carried out. The AE rate was significantly lower (p<0.01) in the topical (0%) vs. the injectable group (4.2%). The most common AE was pain during the post-operative period. All AEs were managed conservatively and resolved without sequeale. 96.7% of participants were satisfied with the appearance of the healed penis and 100% would recommend the ShangRing to others. All seven male circumcision providers involved in the study preferred topical to injectable anaesthesia. CONCLUSIONS: Our results demonstrate the safety, improved clinical experience, effectiveness, and acceptability of the use of topical anaesthesia in ShangRing circumcision using the no-flip technique. Topical anaesthesia effectively eliminates needlestick pain from the clients' VMMC experience and thus has the potential to increase demand for the service. TRIAL REGISTRATION: ClinicalTrials.gov NCT02390310.