No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya
Omar Al Hussein Alawamlh, Quentin D Awori, Mark A Barone, Soo-Jeong Kim, Marc Goldstein, Philip S Li, Richard K Lee, Omar Al Hussein Alawamlh, Quentin D Awori, Mark A Barone, Soo-Jeong Kim, Marc Goldstein, Philip S Li, Richard K Lee
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<0.0001). Median dwell time of the topical anesthetic was 43 (IQR: 35.5-60) minutes, while the median time it took the injectable anesthetic to take effect was 2.04 (IQR: 1.72-3.09) minutes.
Conclusion: No-flip ShangRing circumcision had a positive safety profile among young adolescent boys, specifically ages 10-12 years. The use of spontaneous device detachment and topical anesthesia with the procedure have shown promising outcomes in this age group. This may have the potential to further increase the acceptability of ShangRing circumcision, and therefore accelerate the scle up of male circumcision services in sub-Saharan Africa.
Trial registration: ClinicalTrials.gov registration # NCT02390310.
Conflict of interest statement
The authors declare that no competing interests exist. The funder provided support in the form of salaries for authors MAB, PSL, RKL, and QDA via the grant that supported this work. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The specific roles of these authors are articulated in the ‘author contributions’ section
Figures
References
- Tobian AA, Kigozi G, Wawer MJ, Serwadda D, Quinn TC, Gray RH. Herpes simplex virus type-2 assay specificity and male circumcision to reduce herpes simplex virus type-2 acquisition. AIDS (London, England). 2013;27(1):147–9.
- Tobian AA, Serwadda D, Quinn TC, Kigozi G, Gravitt PE, Laeyendecker O, et al. Male circumcision for the prevention of HSV-2 and HPV infections and syphilis. The New England journal of medicine. 2009;360(13):1298–309. 10.1056/NEJMoa0802556
- Tobian AA, Gray RH. The medical benefits of male circumcision. Jama. 2011;306(13):1479–80. 10.1001/jama.2011.1431
- Pintye J, Baeten JM, Manhart LE, Celum C, Ronald A, Mugo N, et al. Association between male circumcision and incidence of syphilis in men and women: a prospective study in HIV-1 serodiscordant heterosexual African couples. The Lancet Global health. 2014;2(11):e664–71. 10.1016/S2214-109X(14)70315-8
- Tobian AA, Gray RH, Quinn TC. Male circumcision for the prevention of acquisition and transmission of sexually transmitted infections: the case for neonatal circumcision. Archives of pediatrics & adolescent medicine. 2010;164(1):78–84.
- WHO, JHPIEGO. Manual for early infant male circumcision under local anesthesia. Geneva: World Health Organization; 2011.
- WHO. Progress in scaling up voluntary medical male circumcision for HIV prevention in East and Southern Africa, January–December 2012. In: Africa WROf, editor. Republic of Congo: World Health Organization; 2013.
- WHO. WHO Progress Brief: Voluntary Medical Male Circumcision for HIV Prevention in 14 Priority Countries in East and Southern Africa. Geneva: World Health Organization; 2016.
- Kigozi G, Musoke R, Watya S, Kighoma N, Ssebbowa P, Serwadda D, et al. The acceptability and safety of the Shang Ring for adult male circumcision in Rakai, Uganda. Journal of acquired immune deficiency syndromes (1999). 2013;63(5):617–21.
- Sokal DC, Li PS, Zulu R, Awori QD, Combes SL, Simba RO, et al. Randomized controlled trial of the shang ring versus conventional surgical techniques for adult male circumcision: safety and acceptability. Journal of acquired immune deficiency syndromes (1999). 2014;65(4):447–55.
- Barone MA, Li PS, Lee RK, Ouma D, Oundo M, Barasa M, et al. Simplifying the ShangRing technique for circumcision in boys and men: use of the no-flip technique with randomization to removal at 7 days versus spontaneous detachment. Asian journal of andrology. 2019;21(4):324–31. 10.4103/aja.aja_91_18
- Awori Q, Li PS, Lee RK, Ouma D, Oundo M, Barasa M, et al. Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial. PloS one. 2019;14(8):e0218066 10.1371/journal.pone.0218066
- WHO. A framework for voluntary medical male circumcision: effective HIV prevention and a gateway to improved adolescent boys' & men's health in Eastern and Southern Africa by 2021. World Health Organization; 2016.
- WHO Prequalification of Male Circumcision Devices Public Report Product: ShangRingTM Number: PQMC 0003-003-00, version 3.0. [Internet]. Geneva; March, 2019. Available from: . 2019.
- Lei JH, Liu LR, Lu X, Cheng SH, Cai YC, Chen YJ, et al. [Circumcision with no-flip Shang Ring technique for adult males: analysis of 168 cases]. Zhonghua nan ke xue = National journal of andrology. 2014;20(4):320–4.
- Yang BH, Jia C, Liu T, Peng YF. [Novel no-flip Shang Ring circumcision for adult males: a clinical application study of 528 cases]. Zhonghua nan ke xue = National journal of andrology. 2014;20(8):709–14.
- Cao DH, Liu LR, Yang L, Qian SQ, Lei JH, Yuan JH, et al. [No-flip method versus external method for Shang Ring circumcision: a meta-analysis]. Zhonghua nan ke xue = National journal of andrology. 2014;20(12):1113–9.
- WHO. Framework for clinical evaluation of devices for male circumcision, Geneva. 2012.
- WHO. WHO Technical Advisory Group on Innovations in Male Circumcision: Evaluation of two adult devices. Geneva, Switzerland: World Health Organization; 2013.
- Rech D SC, Hatzold K, Ridzon R. Adverse Event Action Guid. . 2014.
- Organization WH. WHO Technical Advisory Group on innovations in male circumcision, meeting report. Geneva, Switzerland: WHO; 2015.
- Al Hussein Alawamlh O, Kim SJ, Li PS, Lee RK. Novel Devices for Adolescent and Adult Male Circumcision. European urology focus. 2018;4(3):329–32. 10.1016/j.euf.2018.06.015
- Awori QD, Lee RK, Li PS, Zulu R, Agot K, Combes S, et al. Surgical Outcomes of Newly Trained ShangRing Circumcision Providers. Journal of acquired immune deficiency syndromes (1999). 2016;72 Suppl 1:S13–7.
- Fang L, Zhu W, Xie Z, Wu K, Wang G, Yan Z, et al. Choosing the appropriate ShangRing size for paediatric circumcision using the no-flip technique. Journal of paediatrics and child health. 2017.
- Awori QD, Lee RK, Li PS, Moguche JN, Ouma D, Sambai B, et al. Use of the ShangRing circumcision device in boys below 18 years old in Kenya: results from a pilot study. Journal of the International AIDS Society. 2017;20(1):21588 10.7448/IAS.20.1.21588
Source: PubMed