N/A
N=150
A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision
Circumcision
Bottom Line
View on ClinicalTrials.gov: NCT01877408 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Intraoperative Duration — 22.6; 13.0; 25.0; 28.6 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Open surgical circumcision (Procedure); Unicirc device with tissue adhesive (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Simunye Primary Health Care
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Duration |
22.6; 13.0; 25.0; 28.6 | — |
| SECONDARY Difficulty in Learning and Performing Technique |
2 | — |
| SECONDARY Number of Participants With Complete Wound Healing by Post-Surgery Week 4 |
49; 89 | — |
| SECONDARY Pain Experienced |
3.1; 4.2; 1.2; 0.7 | — |
| SECONDARY Overall Patient Satisfaction |
40; 78; 8; 15; 2; 5 | — |
| SECONDARY Cosmetic Result |
20; 79; 8; 12; 22; 7 | — |
Summary
To identify a minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.
Eligibility Criteria
Inclusion Criteria
- Healthy men at least 18 years of age requesting circumcision
- No anatomical penile 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 (NCT01877408). 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.