A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision

• Intraoperative duration [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Time is takes for procedure from first manipulation of tissue under local anesthesia to dressing.
  
  

• Difficulty in learning and performing technique [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Evaluated by doctor survey, 5 point Likert scale
  
  
• Time required for healing [ Time Frame: Within 6 weeks after surgery ] [ Designated as safety issue: Yes ]
  Time required for healing
  
  
• Direct costs [ Time Frame: Within 6 weeks after surgery ] [ Designated as safety issue: No ]
  the cost of labor, supplies and equipment
  
  
• Pain experienced [ Time Frame: 2 days after surgery ] [ Designated as safety issue: Yes ]
  Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale.
  
  
• Overall Patient satisfaction [ Time Frame: Within 6 weeks after surgery ] [ Designated as safety issue: No ]
  Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.
  
  
• Cosmetic result [ Time Frame: Within 6 weeks after surgery ] [ Designated as safety issue: No ]
  Cosmetic result evaluated with patient satisfaction questionnaire using five point Likert scale.
  
  

• Adverse events [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
  Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection
  
  

Voluntary medical male circumcision (VMMC) is a priority preventive intervention and Mozambique is a priority country for VMMC scale-up. PEPFAR recently estimated that one HIV infection would be prevented between now and 2025 for every seven circumcisions performed in Mozambique. Sofala Province, where the study will be conducted, has an HIV prevalence of 13% among men and 18% among women. Approximately 8% of men aged 15-49 in Sofala Province, where the study will take place, are currently circumcised.

In spite of their widely acknowledged drawbacks, open surgical techniques are the only VMMC techniques the PEPFAR program currently allows in Africa. According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."

This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and PEPFAR to more effectively scale-up circumcision services. The investigators postulate that VMMC using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and is more cost effective than any other currently available technique.

The investigators propose a randomized controlled trial (RCT) comparing this minimally-invasive circumcision technique to the open surgical technique:

• Gomco clamp with tissue adhesive: 100 men
• Open surgical circumcision: 100 men

The Gomco clamp is an FDA-approved device widely used in the US, but there are few data on its use in Africa. Tissue adhesive is widely used in multiple areas of medicine; specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue adhesives to be superior to suture closure in circumcision in boys. The investigators refer to Gomco clamp circumcision coupled with tissue adhesive as a 'new' technique because these two independently-validated components have only been coupled in observational studies among men, and in randomized controlled trials among pre-pubertal boys, but never before in an RCT among adult men. The open surgical method is PEPFAR-approved and will serve as the control intervention.

Population: Men > 18 years of age who desire male circumcision Sample size: 200 (100 men in each group) Study design: Randomized controlled trial Intervention: Gomco clamp circumcision plus tissue adhesive vs. open surgical circumcision Follow-up visits: 2 days, 7 days, 14 days and 28 days. Optional 42 day follow-up if not completely healed by 4 weeks.