cornellbrady1's video: Safety and Efficacy of No-flip ShangRing Circumcision in Young Adolescent Boys in Kenya

Safety and Efficacy of No-flip ShangRing Circumcision in Young Adolescent Boys in Kenya Omar Al Hussein Alawamlh*, Ryan Flannigan, Quentin Awori, Soo Jeong Kim, Mark Barone, Marc Goldstein, Philip S. Li, Richard K. Lee, New York, NY INTRODUCTION AND OBJECTIVES: With recent efforts to scale-up male circumcision (MC) in sub- Saharan Africa for the prevention of HIV transmission, the attention of the Joint United Nations Programme on HIV/AIDS (UNAIDS) has recently turned towards device-assisted MC, with increasing emphasis on younger age groups. The ShangRing (SR) is one of two World Health Organization (WHO) pre-qualified devices for MC. In this study, we assess the safety and efficacy of SR MC in 10 to 12- year-old boys compared to older males in Kenya. METHODS: Young adolescent boys aged 10-12 years were enrolled in two randomized clinical trials (RCTs) at two study sites in Kenya. All participants underwent MC using the no-flip SR technique, which involves the insertion of an inner plastic ring under the foreskin followed by secure clamping of an outer ring to provide hemostatic occlusion. The foreskin distal to the device is then excised. Adverse events (AE), pain scores using the Visual Analogue Pain Scale (VAS), time to complete wound healing, and participant satisfaction with cosmoses were recorded. Data for 10-12-year-old participants were combined from both RCTs and compared to that of participants aged greater than 13 years. RESULTS: A total of 574 participants were enrolled, of which 197 (34%) were aged 10-12 years. All (100%) participants were successfully circumcised with the no-flip SR technique. 4 (2.0%) procedure related AEs were reported in the 10-12 age group vs. 9 (2.4%) in the older participants (p equal to 0.07). All AEs were of mild or moderate grade. Mean pain scores 20 minutes post-operatively were similar in both age groups (1.91 vs. 1.62, p equal to 0.11). Complete wound healing was demonstrated in 100% of 10- 12-year-old boys at 42 days vs. 81% of the older participants (p smaller than 0.0001). The vast majority of both age groups were very satisfied with the appearance of the healed penis post-circumcision (96% of 10- 12 age group vs. 98% of those greater than 13 years, p=0.16) (Table 1). CONCLUSIONS: No-flip SR MC in young adolescent boys aged 10 to 12 years old is safe, effective, and acceptable, demonstrating comparable AE rates, pain scores, and satisfaction compared to older age groups, with superior wound healing. Further studies are needed to assess its use in boys under 10 years of age.