Abstract
BackgroundThe 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.ObjectivesWe 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.MethodsParticipants 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.ResultsCompared 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.ConclusionsOur 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 registrationClinicalTrials.gov NCT02390310.
Highlights
Male circumcision was proven to be effective in limiting the rate of female to male transmission of HIV in three randomised control trials (RCTs) by up to 60% [1,2,3] and could avert an estimated 3.7 million new infections between 2016–2026[4]
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
The analysis looked at information on the progress of the study as well as data on adverse event (AE), procedure times, problems encountered during the circumcisions, and proportion of participants healed by 42 days; these were all categorized by age and treatment group
Summary
Male circumcision was proven to be effective in limiting the rate of female to male transmission of HIV in three randomised control trials (RCTs) by up to 60% [1,2,3] and could avert an estimated 3.7 million new infections between 2016–2026[4] This protective effect was shown to last for at least 5 to 6 years [5,6]. As part of the continued efforts towards achievement of 80% coverage, improvements in the planning [10,11], demand creation [12], service provision [13] and surgical technique have been widely researched and adopted Despite considerable progress, these goals were not achieved in the original timeline [14]; new goals outlined in the WHO 2016–2021 VMMC framework aim to have 90% of males 10–29 years circumcised by 2021 [15].
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