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Randomized Controlled Trial of the Shang Ring Versus Conventional Surgical Techniques for Adult Male Circumcision: Safety and Acceptability

Sokal, David C. MD*; Li, Philip S. MD; Zulu, Robert MMed; Awori, Quentin D. MBChB§; Combes, Stephanie L. MA*; Simba, Raymond O. MBChB; Lee, Richard MD; Hart, Catherine AAS*; Perchal, Paul MA; Hawry, Hayden J. MHS#; Bowa, Kasonde FRCS‡,**; Goldstein, Marc MD; Barone, Mark A. DVM

JAIDS Journal of Acquired Immune Deficiency Syndromes: April 1st, 2014 - Volume 65 - Issue 4 - p 447–455
doi: 10.1097/QAI.0000000000000061
Clinical Science

Objective: To compare clinical profiles of Shang Ring versus conventional circumcisions.

Design: Parallel group open-label randomized controlled trial with one-to-one allocations in 2 sites.

Methods: We enrolled HIV-negative men aged 18–54 years in Homa Bay, Kenya, and Lusaka, Zambia and followed them at 2, 7, 14, 21, 28, 42, and 60 days after Shang Ring versus conventional circumcision. We compared the duration of surgery, postoperative pain using a visual analog scale, adverse events rates, time to complete wound healing by clinical assessment, participant acceptability, and provider preferences between circumcision groups.

Results: We randomized 200 men to each group; 197 and 201 contributed to the Shang Ring and conventional surgery analyses, respectively. Adverse event rates were similar between groups. Pain scores at most time points were similar, however, the Shang Ring group reported higher scores for worst pain during erections (3.5 ± 1.9 vs. 2.3 ± 1.7; P < 0.001). Significantly more men were satisfied with the cosmetic appearance following Shang Ring male circumcision (MC), 95.7% versus 85.9% (P = 0.02) in Kenya, and 96.8% versus 71.3% (P < 0.01) in Zambia. Although median time to complete wound healing was 43 days in both groups, conventional circumcisions healed on average 5.2 days sooner (P < 0.001). Shang Ring procedures took one-third the time of conventional MC, 7 versus 20 minutes. All circumcision providers preferred the Shang Ring.

Conclusions: Safety profiles of the 2 techniques were similar, all MC providers preferred the Shang Ring technique, and study participants preferred the Shang Ring's cosmetic results. The Shang Ring should be considered for adult MC as programs scale-up.

*Clinical Sciences Unit, FHI 360, Durham, NC;

Center for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, NY;

University Teaching Hospital, Lusaka, Zambia;

§EngenderHealth, Kisumu, Kenya;

Homa Bay District Hospital, Homa Bay, Kenya;

EngenderHealth, New York, NY;

#Society for Family Health, Lusaka, Zambia; and

**Copperbelt University School of Medicine, Kitwe, Zambia.

Correspondence to: Stephanie L. Combes, MA, FHI 360, 2224 East NC Highway 54, Durham, NC 27713 (e-mail: scombes@fhi360.org).

Supported by a Grant from the Bill and Melinda Gates Foundation to FHI 360 (Grant OPPGH5166).

Presented at the International Conference on AIDS and Sexually Transmitted Infections in Africa (ICASA), December 4–8, 2011, Addis Ababa, Ethiopia; Annual meeting of the University of Nairobi Collaborative Centre for Research and Training in HIV/AIDS/STIs, January 23–27, 2012, Nairobi, Kenya; Annual meeting of the American Urological Association, May 19–23, 2012 (por), Atlanta, GA; and 2012 Meeting of the International AIDS Society, July 21–27, 2012, Washington, DC. Abstract no. TUAC0404.

The authors have no conflicts of interest to disclose.

D.C.S. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. D.C.S. was a member of the Protocol Executive Committee and was overall team leader for the study. He provided scientific leadership, and participated in drafting the protocol, study implementation, analysis, and drafting the article. P.S.L. was a member of the Protocol Executive Committee and clinical leader for the study. He prepared surgical training material, helped interpret the results, and reviewed the article. R.Z. was the site clinician for the Zambia site and was involved in data collection and interpretation, and reviewed the article. Q.D.A. helped with training of study staff, study co-ordination, data collection (informed consent process, performing surgical procedures, and follow-up visits), verification and management, data analysis and interpretation, presented the results in various forums and reviewed the article. S.L.C. participated in the design and conduct of the study, including preparation of the protocol and other study documents, provided overall coordination for the study, and managed and performed training activities, data analysis and interpretation, and reviewed and finalized the article. R.O.S. was the senior clinician at the Kenya site, performed some MC procedures and helped evaluate and interpret adverse events and time to healing data and reviewed the article. R.L. helped with data analysis and interpretation and reviewed the article. C.H. assisted with study design, data collection, study specific training, clinical monitoring, and review of the acceptability data. P.P. contributed review of findings, article review, and provided administrative support. H.J.H. contributed to review of the study instruments, study implementation, administrative support in Lusaka, and reviewed the article. K.B. was the clinical leader for the Zambia site, and provided scientific leadership, guidance on ethical issues and reviewed the article. M.G. mentored the Weill Cornell Medical College study team and helped interpret the results and finalize the article. M.A.B. was a member of the Protocol Executive Committee. He participated in the design and conduct of all aspect of the study, including providing scientific leadership, writing the protocol, developing the study instruments, managing oversight for the Kenya study site, interpreting study data, and drafting the article.

Trial registration: NCT01300910 at ClinicalTrials.gov. Ethical committee approvals for the trial were obtained from FHI 360, the Kenya Medical Research Institute, and the University of Zambia. The Zambia Ministry of Health also granted permission to conduct the study.

Received August 05, 2013

Accepted November 02, 2013

© 2014 by Lippincott Williams & Wilkins