Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01688310
Recruitment Status : Completed
First Posted : September 19, 2012
Results First Posted : September 10, 2013
Last Update Posted : September 10, 2013
Sponsor:
Collaborators:
University of Pittsburgh
Catholic University of Mozambique
Information provided by (Responsible Party):
Dr. Peter Millard, Universidade Católica de Moçambique

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Surgical Technique
Interventions Procedure: Gomco Clamp with Tissue Adhesive
Procedure: Open surgical circumcision
Enrollment 200
Recruitment Details Recruitment between October 30, 2012 and February 2, 2013. University teaching clinic.
Pre-assignment Details

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
Arm/Group Title Open Surgical Circumcision Gomco Clamp With Tissue Adhesive
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 100 100
Completed 100 100
Not Completed 0 0
Arm/Group Title Open Surgical Circumcision Gomco Clamp With Tissue Adhesive Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 200 participants
22.8  (4.9) 22.3  (4.7) 22.5  (4.8)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
18-20 yrs 43 49 92
21-24 yrs 26 27 53
>=25 yrs 31 24 55
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
100
 100.0%
100
 100.0%
200
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mozambique Number Analyzed 100 participants 100 participants 200 participants
100 100 200
1.Primary Outcome
Title Intraoperative Duration
Hide Description Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Open Surgical Circumcision Gomco Clamp With Tissue Adhesive
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 100 100
Mean (Standard Deviation)
Unit of Measure: Min
22.5  (6.6) 12.8  (2.7)
2.Secondary Outcome
Title Difficulty in Learning and Performing Technique
Hide Description

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 Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Senior Physicians Junior Physicians
Hide Arm/Group Description:
Physicians who had extensive prior experience performing open surgical circumcisions.
Physicians who had very limited prior experience performing open surgical circumcisions.
Overall Number of Participants Analyzed 4 9
Median (Full Range)
Unit of Measure: units on Likert scale
2.5
(1 to 5)
2
(1 to 5)
3.Secondary Outcome
Title Time Required for Healing
Hide Description Time required for healing
Time Frame Within 6 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Surgical Circumcision Gomco Clamp With Tissue Adhesive
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 97 96
Measure Type: Number
Unit of Measure: percentage of participants
Healed at 2 weeks 2.1 9.4
Healed at 4 weeks 87.8 87.4
Healed at 6 weeks 98.9 100
4.Secondary Outcome
Title Direct Costs
Hide Description the cost of labor, supplies and equipment
Time Frame Within 6 weeks after surgery
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Pain Experienced
Hide Description Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)
Time Frame 2 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Surgical Circumcision Gomco Clamp With Tissue Adhesive
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 100 100
Mean (Standard Deviation)
Unit of Measure: units on 10 point pain scale
2.5  (1.9) 1.8  (1.6)
6.Secondary Outcome
Title Overall Patient Satisfaction
Hide Description Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.
Time Frame Within 6 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Surgical Circumcision Gomco Clamp With Tissue Adhesive
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 99 95
Measure Type: Number
Unit of Measure: participants
Very satisfied 70 56
Satisfied 29 39
Not satisfied 0 0
7.Secondary Outcome
Title Cosmetic Result
Hide Description Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).
Time Frame Within 6 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Surgical Circumcision Gomco Clamp With Tissue Adhesive
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 93 94
Measure Type: Number
Unit of Measure: participants
Regular 54 93
Irregular 35 1
Scalloped 4 0
8.Other Pre-specified Outcome
Title Adverse Events
Hide Description Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection
Time Frame 1 yr
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Surgical Circumcision Gomco Clamp With Tissue Adhesive
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 100 100
Measure Type: Number
Unit of Measure: participants
Mild bleeding 0 4
Moderate bleeding (suturing required) 1 6
Hematoma 3 1
Infection (antibiotic required) 3 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Surgical Circumcision Gomco Clamp With Tissue Adhesive
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Open Surgical Circumcision Gomco Clamp With Tissue Adhesive
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Open Surgical Circumcision Gomco Clamp With Tissue Adhesive
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/100 (0.00%)      0/100 (0.00%)    
Surgical and medical procedures     
Serious post-operative complication  0/100 (0.00%)  0 0/100 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open Surgical Circumcision Gomco Clamp With Tissue Adhesive
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/100 (7.00%)      18/100 (18.00%)    
Surgical and medical procedures     
Mild post-operative bleeding   0/100 (0.00%)  0 4/100 (4.00%)  4
Moderate post-operative bleeding  [1]  1/100 (1.00%)  1 6/100 (6.00%)  6
Hematoma   3/100 (3.00%)  3 1/100 (1.00%)  1
Post-operative infection  [2]  3/100 (3.00%)  3 7/100 (7.00%)  7
Indicates events were collected by systematic assessment
[1]
Required suturing to stop bleeding
[2]
Required antibiotic
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Peter Millard
Organization: Catholic University of Mozambique Medical School
Phone: 2078663503
EMail: pmillard@mac.com
Publications:
World Health Organization. Male circumcision: Global trends and determinants of prevalence, safety and acceptability, 2007
World Health Organization. Manual for Male Circumcision under Local Anaesthesia. 2009.
World Health Organization. Manual for early infant male circumcision under local anaesthesia. 2010.
World Health Organization. Framework for Clinical Evaluation of Devices for Adult Male Circumcision. 2011.
PEPFAR Next Generation Indicators Reference Guide, Vers 1.1, 2009 At www.pepfar.gov/documents/organization/81097.pdf
Layout table for additonal information
Responsible Party: Dr. Peter Millard, Universidade Católica de Moçambique
ClinicalTrials.gov Identifier: NCT01688310    
Other Study ID Numbers: PRO11080657
First Submitted: August 27, 2012
First Posted: September 19, 2012
Results First Submitted: June 7, 2013
Results First Posted: September 10, 2013
Last Update Posted: September 10, 2013