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

Not Applicable

Completed

Conditions: Surgical Technique

Interventions: Procedure: Open surgical circumcision
Procedure: Gomco Clamp with Tissue Adhesive

Registration Number: NCT01688310

Lead Sponsor: Universidade Católica de Moçambique

Brief Summary: This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and global health programs to more effectively scale-up circumcision services. The investigators postulate that voluntary medical male circumcision 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.

Detailed Description: 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 President's Emergency Plan for AIDS Relief (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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 200

Inclusion Criteria

Healthy men > 18 years of age requesting circumcision
No penile anatomical abnormalities or infections
Able to provide informed consent to participate
Willing to participate in follow-up visits

Exclusion Criteria

Current illness
Penile abnormality or infection which contraindicates or would complicate circumcision
History of bleeding disorder
Past reaction to local anesthetic

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open surgical circumcision	Open surgical circumcision	Open surgical techniques, which are commonly used for circumcision in Mozambique, require good surgical skills and minor complications are common.
Gomco clamp with tissue adhesive	Gomco Clamp with Tissue Adhesive	Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.

Primary Outcome Measures

Name	Time	Method
Intraoperative Duration	1 year	Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.

Secondary Outcome Measures

Name	Time	Method
Difficulty in Learning and Performing Technique	1 year	Evaluated by doctor survey, 5 point Likert scale: 1. Gomco technique is much easier 2. Gomco technique is easier 3. Neutral 4. Open surgical technique is easier 5. Open surgical technique is much easier
Time Required for Healing	Within 6 weeks after surgery	Time required for healing
Direct Costs	Within 6 weeks after surgery	the cost of labor, supplies and equipment
Pain Experienced	2 days after surgery	Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)
Overall Patient Satisfaction	Within 6 weeks after surgery	Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.
Cosmetic Result	Within 6 weeks after surgery	Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).