title: Randomized controlled trial of the shang ring versus conventional surgical techniques for adult male circumcision: safety and acceptability.
abstract: OBJECTIVE
  To compare clinical profiles of Shang Ring versus conventional circumcisions.
  
  
  METHODS
  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.
authors.affiliation: *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.
authors.forename: David C
authors.initials: DC
authors.lastname: Sokal
authors.forename: Philip S
authors.initials: PS
authors.lastname: Li
authors.forename: Robert
authors.initials: R
authors.lastname: Zulu
authors.forename: Quentin D
authors.initials: QD
authors.lastname: Awori
authors.forename: Stephanie L
authors.initials: SL
authors.lastname: Combes
authors.forename: Raymond O
authors.initials: RO
authors.lastname: Simba
authors.forename: Richard
authors.initials: R
authors.lastname: Lee
authors.forename: Catherine
authors.initials: C
authors.lastname: Hart
authors.forename: Paul
authors.initials: P
authors.lastname: Perchal
authors.forename: Hayden J
authors.initials: HJ
authors.lastname: Hawry
authors.forename: Kasonde
authors.initials: K
authors.lastname: Bowa
authors.forename: Marc
authors.initials: M
authors.lastname: Goldstein
authors.forename: Mark A
authors.initials: MA
authors.lastname: Barone
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects* / Q000379:methods* / Q000523:psychology; D005500:Follow-Up Studies; D006801:Humans; D007630:Kenya; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data*; D013514:Surgical Procedures, Operative / Q000009:adverse effects* / Q000379:methods* / Q000523:psychology; D055815:Young Adult; D015024:Zambia