N/A
N=200
A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision
Surgical Technique
Bottom Line
View on ClinicalTrials.gov: NCT01688310 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Intraoperative Duration — 22.5; 12.8 Min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gomco Clamp with Tissue Adhesive (Procedure); Open surgical circumcision (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Universidade Católica de Moçambique
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Duration |
22.5; 12.8 | — |
| SECONDARY Difficulty in Learning and Performing Technique |
2.5; 2 | — |
| SECONDARY Time Required for Healing |
2.1; 9.4; 87.8; 87.4; 98.9; 100 | — |
| SECONDARY Direct Costs |
— | — |
| SECONDARY Pain Experienced |
2.5; 1.8 | — |
| SECONDARY Overall Patient Satisfaction |
70; 56; 29; 39; 0; 0 | — |
| SECONDARY Cosmetic Result |
54; 93; 35; 1; 4; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01688310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.