1. No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya
- Author
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Omar Al Hussein Alawamlh, Quentin D. Awori, Mark A. Barone, Soo-Jeong Kim, Marc Goldstein, Philip S. Li, and Richard K. Lee
- Subjects
Male ,0301 basic medicine ,Pediatrics ,Physiology ,Topical Anesthesia ,Systems Science ,law.invention ,0302 clinical medicine ,Topical anesthesia ,Randomized controlled trial ,Circumcision ,Anesthesiology ,law ,Medicine and Health Sciences ,Anesthesia ,030212 general & internal medicine ,Reproductive System Procedures ,Anesthetics, Local ,Child ,Multidisciplinary ,Pharmaceutics ,Drugs ,Safety profile ,Baseline characteristics ,Physical Sciences ,Medicine ,Anatomy ,Genital Anatomy ,Research Article ,Computer and Information Sciences ,medicine.medical_specialty ,Science ,Surgical and Invasive Medical Procedures ,Topical anesthetic ,03 medical and health sciences ,Drug Therapy ,Tissue Repair ,medicine ,Pain Management ,Humans ,Adverse effect ,Anesthetics ,Pharmacology ,Wound Healing ,Pain score ,business.industry ,Reproductive System ,Biology and Life Sciences ,Kenya ,030112 virology ,Clinical trial ,Circumcision, Male ,Age Groups ,People and Places ,Population Groupings ,Local and Regional Anesthesia ,Physiological Processes ,business ,Mathematics ,Dwell Time ,Penis - Abstract
Background Attention has recently turned toward the use of device-assisted male circumcision to help scale up male circumcision services in sub-Saharan Africa, with increasing emphasis on younger age groups. We assessed the use of the ShangRing for circumcising the subset of boys aged 10 to 12 years who were enrolled in two randomized clinical trials in Kenya. Methods We performed a sub-analysis of outcomes in 197 boys aged 10 to 12 years; a subset who were enrolled in two randomized clinical trials to assess the use of the no-flip ShangRing circumcision technique in men and boys. One trial assessed spontaneous detachment vs. planned removal of the ShangRing 7 days post-circumcision. The second trial compared the use of topical vs. injectable anesthesia with ShangRing circumcision. Aside from baseline characteristics, data was collected and analyzed for each trial separately. Results All participants were successfully circumcised. Duration of circumcision, participants requiring a dorsal slit, rate of adverse events, time to complete wound healing, and participant satisfaction were similar between the two groups in each trial. Mean time required for spontaneous ShangRing detachment was 14.82±3.76 days. Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p
- Published
- 2020