Trial Outcomes & Findings for A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision (NCT NCT01688310)
NCT ID: NCT01688310
Last Updated: 2013-09-10
Results Overview
Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
1 year
Results posted on
2013-09-10
Participant Flow
Recruitment between October 30, 2012 and February 2, 2013. University teaching clinic.
241 interviewed, Excluded (n=41) * Inclusion criteria not met (n=19) * Under 18 years of age (n=17) * Phimosis (n=2) * Declined to participate (n=22) 200 were randomized and underwent circumcision in the arm allocated
Participant milestones
| Measure |
Open Surgical Circumcision
Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision
Baseline characteristics by cohort
| Measure |
Open Surgical Circumcision
n=100 Participants
Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
|
Gomco Clamp With Tissue Adhesive
n=100 Participants
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.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
22.8 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
22.3 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
22.5 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Age, Customized
18-20 yrs
|
43 participants
n=5 Participants
|
49 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Age, Customized
21-24 yrs
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Age, Customized
>=25 yrs
|
31 participants
n=5 Participants
|
24 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Region of Enrollment
Mozambique
|
100 participants
n=5 Participants
|
100 participants
n=7 Participants
|
200 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All participants
Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.
Outcome measures
| Measure |
Open Surgical Circumcision
n=100 Participants
Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
|
Gomco Clamp With Tissue Adhesive
n=100 Participants
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.
|
|---|---|---|
|
Intraoperative Duration
|
22.5 Min
Standard Deviation 6.6
|
12.8 Min
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 1 yearEvaluated 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
Outcome measures
| Measure |
Open Surgical Circumcision
n=4 Participants
Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
|
Gomco Clamp With Tissue Adhesive
n=9 Participants
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.
|
|---|---|---|
|
Difficulty in Learning and Performing Technique
|
2.5 units on Likert scale
Interval 1.0 to 5.0
|
2 units on Likert scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Within 6 weeks after surgeryTime required for healing
Outcome measures
| Measure |
Open Surgical Circumcision
n=97 Participants
Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
|
Gomco Clamp With Tissue Adhesive
n=96 Participants
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.
|
|---|---|---|
|
Time Required for Healing
Healed at 2 weeks
|
2.1 percentage of participants
|
9.4 percentage of participants
|
|
Time Required for Healing
Healed at 4 weeks
|
87.8 percentage of participants
|
87.4 percentage of participants
|
|
Time Required for Healing
Healed at 6 weeks
|
98.9 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Within 6 weeks after surgerythe cost of labor, supplies and equipment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 days after surgeryPain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)
Outcome measures
| Measure |
Open Surgical Circumcision
n=100 Participants
Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
|
Gomco Clamp With Tissue Adhesive
n=100 Participants
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.
|
|---|---|---|
|
Pain Experienced
|
2.5 units on 10 point pain scale
Standard Deviation 1.9
|
1.8 units on 10 point pain scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Within 6 weeks after surgeryPatient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.
Outcome measures
| Measure |
Open Surgical Circumcision
n=99 Participants
Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
|
Gomco Clamp With Tissue Adhesive
n=95 Participants
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.
|
|---|---|---|
|
Overall Patient Satisfaction
Not satisfied
|
0 participants
|
0 participants
|
|
Overall Patient Satisfaction
Very satisfied
|
70 participants
|
56 participants
|
|
Overall Patient Satisfaction
Satisfied
|
29 participants
|
39 participants
|
SECONDARY outcome
Timeframe: Within 6 weeks after surgeryCosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).
Outcome measures
| Measure |
Open Surgical Circumcision
n=93 Participants
Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
|
Gomco Clamp With Tissue Adhesive
n=94 Participants
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.
|
|---|---|---|
|
Cosmetic Result
Regular
|
54 participants
|
93 participants
|
|
Cosmetic Result
Irregular
|
35 participants
|
1 participants
|
|
Cosmetic Result
Scalloped
|
4 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yrIntraoperative and post-operative adverse events, such as bleeding, hematoma, and infection
Outcome measures
| Measure |
Open Surgical Circumcision
n=100 Participants
Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
|
Gomco Clamp With Tissue Adhesive
n=100 Participants
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.
|
|---|---|---|
|
Adverse Events
Mild bleeding
|
0 participants
|
4 participants
|
|
Adverse Events
Moderate bleeding (suturing required)
|
1 participants
|
6 participants
|
|
Adverse Events
Hematoma
|
3 participants
|
1 participants
|
|
Adverse Events
Infection (antibiotic required)
|
3 participants
|
7 participants
|
Adverse Events
Open Surgical Circumcision
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Gomco Clamp With Tissue Adhesive
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Surgical Circumcision
n=100 participants at risk
Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
|
Gomco Clamp With Tissue Adhesive
n=100 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Serious post-operative complication
|
0.00%
0/100
|
0.00%
0/100
|
Other adverse events
| Measure |
Open Surgical Circumcision
n=100 participants at risk
Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
|
Gomco Clamp With Tissue Adhesive
n=100 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Mild post-operative bleeding
|
0.00%
0/100
|
4.0%
4/100 • Number of events 4
|
|
Surgical and medical procedures
Moderate post-operative bleeding
|
1.0%
1/100 • Number of events 1
|
6.0%
6/100 • Number of events 6
|
|
Surgical and medical procedures
Hematoma
|
3.0%
3/100 • Number of events 3
|
1.0%
1/100 • Number of events 1
|
|
Surgical and medical procedures
Post-operative infection
|
3.0%
3/100 • Number of events 3
|
7.0%
7/100 • Number of events 7
|
Additional Information
Dr. Peter Millard
Catholic University of Mozambique Medical School
Phone: 2078663503
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place