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

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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

Tracking Information
First Submitted Date  ICMJE August 27, 2012
First Posted Date  ICMJE September 19, 2012
Results First Submitted Date  ICMJE June 7, 2013
Results First Posted Date  ICMJE September 10, 2013
Last Update Posted Date September 10, 2013
Study Start Date  ICMJE August 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2013)
Intraoperative Duration [ Time Frame: 1 year ]
Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
Degree of difficulty [ Time Frame: 1 year ]
Degree of difficulty in learning and performing the technique. Doctor Questionnaire using five point Likert scale.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2013)
  • Difficulty in Learning and Performing Technique [ Time Frame: 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 [ Time Frame: Within 6 weeks after surgery ]
    Time required for healing
  • Direct Costs [ Time Frame: Within 6 weeks after surgery ]
    the cost of labor, supplies and equipment
  • Pain Experienced [ Time Frame: 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 [ Time Frame: Within 6 weeks after surgery ]
    Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.
  • Cosmetic Result [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
  • Complications [ Time Frame: within 6 weeks after surgery ]
    Complications (operative and post-operative) evaluated by direct observation by doctor and study staff and CRF completed.
  • Time required for surgical procedure [ Time Frame: 30 minutes ]
    Length of time required for surgical procedure.
  • Time Required for Healing [ Time Frame: Within 6 weeks after surgery ]
    Time required for healing
  • Direct Costs [ Time Frame: Within 6 weeks after surgery ]
    the cost of labor, supplies and equipment
  • Pain Experienced [ Time Frame: 2 days after surgery ]
    Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale.
  • Overall Patient Satisfaction [ Time Frame: Within 6 weeks after surgery ]
    Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.
  • Cosmetic Result [ Time Frame: Within 6 weeks after surgery ]
    Cosmetic result evaluated with patient satisfaction questionnaire using five point Likert scale.
Current Other Pre-specified Outcome Measures
 (submitted: December 27, 2012)
Adverse Events [ Time Frame: 1 yr ]
Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision
Official Title  ICMJE A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Surgical Technique
Intervention  ICMJE
  • Procedure: Gomco Clamp with Tissue Adhesive
    According to WHO (2011), the Gomco clamp has "…an impeccable safety record. In the USA, where it is estimated that well over 1 million neonates are circumcised each year, the Gomco clamp has become the leading instrument used to perform non-ritual male circumcision." 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 VMMC.
  • Procedure: Open surgical circumcision
    The World Health Organization, in its Manual for Male Circumcision under Local Anaesthesia, describes three open surgical techniques (forceps assisted, dorsal slit and sleeve technique), all three of which involve (a) exposure of subcutaneous tissues and (b) suturing for hemostasis and for skin closure.
Study Arms  ICMJE
  • Active Comparator: Open surgical circumcision
    Open surgical techniques, which are commonly used for circumcision in Mozambique, require good surgical skills and minor complications are common.
    Intervention: Procedure: Open surgical circumcision
  • Experimental: 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.
    Intervention: Procedure: Gomco Clamp with Tissue Adhesive
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mozambique
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01688310
Other Study ID Numbers  ICMJE PRO11080657
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Peter Millard, Universidade Católica de Moçambique
Study Sponsor  ICMJE Universidade Católica de Moçambique
Collaborators  ICMJE
  • University of Pittsburgh
  • Catholic University of Mozambique
Investigators  ICMJE
Principal Investigator: Peter Millard, MD, PhD Universidade Catholic de Mozambique
PRS Account Universidade Católica de Moçambique
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP