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

This study has been completed.
Sponsor:
Collaborators:
University of Pittsburgh
Catholic University of Mozambique
Information provided by (Responsible Party):
Dr. Peter Millard, Universidade Católica de Moçambique
ClinicalTrials.gov Identifier:
NCT01688310
First received: August 27, 2012
Last updated: June 30, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Surgical Technique
Procedure: Gomco Clamp with Tissue Adhesive
Procedure: Open surgical circumcision

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision

Resource links provided by NLM:


Further study details as provided by Universidade Católica de Moçambique:

Primary Outcome Measures:
  • Intraoperative Duration [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.


Secondary Outcome Measures:
  • Difficulty in Learning and Performing Technique [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    Time required for healing

  • Direct Costs [ Time Frame: Within 6 weeks after surgery ] [ Designated as safety issue: No ]
    the cost of labor, supplies and equipment

  • Pain Experienced [ Time Frame: 2 days after surgery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.

  • Cosmetic Result [ Time Frame: Within 6 weeks after surgery ] [ Designated as safety issue: No ]
    Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).


Other Outcome Measures:
  • Adverse Events [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
    Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection


Enrollment: 200
Study Start Date: August 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688310

Locations
Mozambique
Centro de Saúde São Lucas, UCM
Beira, Sofala, Mozambique
Sponsors and Collaborators
Universidade Católica de Moçambique
University of Pittsburgh
Catholic University of Mozambique
Investigators
Principal Investigator: Peter Millard, MD, PhD Universidade Catholic de Mozambique
  More Information

Publications:

Responsible Party: Dr. Peter Millard, Clinical Director of the Health Center, Universidade Católica de Moçambique
ClinicalTrials.gov Identifier: NCT01688310     History of Changes
Other Study ID Numbers: PRO11080657
Study First Received: August 27, 2012
Results First Received: June 7, 2013
Last Updated: June 30, 2013
Health Authority: United States: Institutional Review Board
Mozambique: Ministry of Health (MISAU)

Keywords provided by Universidade Católica de Moçambique:
Gomco clamp instrument
Tissue adhesive
Open surgical circumcision
Minimally-invasive circumcision

ClinicalTrials.gov processed this record on April 17, 2014