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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Technique
• Intervention / Treatment: Procedure: Open surgical circumcision; Procedure: Gomco Clamp with Tissue Adhesive

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: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mozambique
  • Sofala
    • Beira, Sofala, Mozambique
      • Centro de Saúde São Lucas, UCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Duration	Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulty in Learning and Performing Technique	Evaluated by doctor survey, 5 point Likert scale: Gomco technique is much easier; Gomco technique is easier; Neutral; Open surgical technique is easier; Open surgical technique is much easier	1 year
Time Required for Healing	Time required for healing	Within 6 weeks after surgery
Direct Costs	the cost of labor, supplies and equipment	Within 6 weeks after surgery
Pain Experienced	Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)	2 days after surgery
Overall Patient Satisfaction	Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.	Within 6 weeks after surgery
Cosmetic Result	Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).	Within 6 weeks after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection	1 yr

Collaborators and Investigators

• Sponsor: Universidade Católica de Moçambique
• Collaborators: University of Pittsburgh; Catholic University of Mozambique
• Investigators: Principal Investigator: Peter Millard, MD, PhD, Universidade Catholic de Mozambique

Publications and helpful links

General Publications

• Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.
• Bailey RC, Muga R, Poulussen R, Abicht H. The acceptability of male circumcision to reduce HIV infections in Nyanza Province, Kenya. AIDS Care. 2002 Feb;14(1):27-40. doi: 10.1080/09540120220097919.
• Lagarde E, Dirk T, Puren A, Reathe RT, Bertran A. Acceptability of male circumcision as a tool for preventing HIV infection in a highly infected community in South Africa. AIDS. 2003 Jan 3;17(1):89-95. doi: 10.1097/00002030-200301030-00012.
• Scott BE, Weiss HA, Viljoen JI. The acceptability of male circumcision as an HIV intervention among a rural Zulu population, Kwazulu-Natal, South Africa. AIDS Care. 2005 Apr;17(3):304-13. doi: 10.1080/09540120412331299744.
• Mattson CL, Bailey RC, Muga R, Poulussen R, Onyango T. Acceptability of male circumcision and predictors of circumcision preference among men and women in Nyanza Province, Kenya. AIDS Care. 2005 Feb;17(2):182-94. doi: 10.1080/09540120512331325671.
• Halperin DT, Fritz K, McFarland W, Woelk G. Acceptability of adult male circumcision for sexually transmitted disease and HIV prevention in Zimbabwe. Sex Transm Dis. 2005 Apr;32(4):238-9. doi: 10.1097/01.olq.0000149782.47456.5b. No abstract available.
• Bailey RC, Egesah O, Rosenberg S. Male circumcision for HIV prevention: a prospective study of complications in clinical and traditional settings in Bungoma, Kenya. Bull World Health Organ. 2008 Sep;86(9):669-77. doi: 10.2471/blt.08.051482.
• Kim HH, Goldstein M. High complication rates challenge the implementation of male circumcision for HIV prevention in Africa. Nat Clin Pract Urol. 2009 Feb;6(2):64-5. doi: 10.1038/ncpuro1279. Epub 2008 Dec 23.
• Lane V, Vajda P, Subramaniam R. Paediatric sutureless circumcision: a systematic literature review. Pediatr Surg Int. 2010 Feb;26(2):141-4. doi: 10.1007/s00383-009-2475-y. Epub 2009 Aug 26.
• Elmore JM, Smith EA, Kirsch AJ. Sutureless circumcision using 2-octyl cyanoacrylate (Dermabond): appraisal after 18-month experience. Urology. 2007 Oct;70(4):803-6. doi: 10.1016/j.urology.2007.07.002.
• Kaye JD, Kalisvaart JF, Cuda SP, Elmore JM, Cerwinka WH, Kirsch AJ. Sutureless and scalpel-free circumcision--more rapid, less expensive and better? J Urol. 2010 Oct;184(4 Suppl):1758-62. doi: 10.1016/j.juro.2010.03.081. Epub 2010 Aug 21.
• 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

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: August 27, 2012
• First Submitted That Met QC Criteria: September 14, 2012
• First Posted (Estimate): September 19, 2012

Study Record Updates

• Last Update Posted (Estimate): September 10, 2013
• Last Update Submitted That Met QC Criteria: June 30, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Tissue adhesive; Open surgical circumcision; Minimally-invasive circumcision; Gomco clamp instrument
• Other Study ID Numbers: PRO11080657