Randomized Control Trial of Shang Ring Versus Forceps-guided Adult Male Circumcision in Southwestern Uganda.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mbarara University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01757938
First received: December 19, 2012
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

Adult male circumcision (AMC) can reduce the incidence of HIV transmission by 40-60% in sub-Saharan Africa (SSA). The World Health Organisation and Joint United Nations Programme on HIV/AIDS advocate AMC for the reduction of HIV transmission in heterosexual men, and feasibility studies have demonstrated that AMC programmes can be effectively delivered to hyperendemic communities, such as those in SSA. Despite these recommendations, the potential effects of AMC have been attenuated by low uptake, with only 5% of all men who could benefit undergoing surgery to date. Traditional, time-consuming methods of AMC that require formal surgical training limit uptake in low-income countries. Training and implementation by non-physician health providers is dampened by a need to perform approximately 100 procedures to achieve satisfactory operative time and adverse effect rates. The investigators performed a randomised controlled effectiveness study to compare the shang ring (SR) with standard forceps-guided (FG)-AMC in a publicly funded regional referral hospital with a locally trained surgeon in Mbarara, western Uganda.


Condition Intervention
HIV
Procedure: Shang Ring Guided Circumcision
Procedure: Forceps Guided Circumcision

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Shang Ring Versus Forceps-guided Adult Male Circumcision: a Randomized Controlled Effectiveness Study in Southwestern Uganda.

Resource links provided by NLM:


Further study details as provided by Mbarara University of Science and Technology:

Primary Outcome Measures:
  • Procedure Time [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Primary outcomes of interest was procedure time. An assistant measured operative time using a stopwatch. For the SR group, timing began as the ring began to be fitted, and ceased when the foreskin had been excised. For the FG group, timing began at the first incision and ceased when the final suture was completed.

  • Major Complication [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
    We considered a major complication as one requiring assessment by a clinician, including any of: a) SR slippage; b) infection requiring antibiotics, or c) any persistent complication on day 14.


Secondary Outcome Measures:
  • Pain [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Pain scales were measured on post-op day 1, 3, 7, 14, and 21 using a visual analogue scale.

  • Time to resumption of normal activity [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Self-reported time to resumption of normal activity (defined as attendance at university classes)

  • Patient Satisfaction [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Patient satisfaction taken at conclusion of follow-up (rated as 'low', 'average', 'high' or "very high" and dichotomized as low/average or high/very high for analyses)

  • Time to complete healing [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    As measured by primary surgeon (study primary investigator) at follow-up visits. Missing outcome data for patients in the FG group who did not return were allocated as favourable for analysis of outcomes to bias estimates of a superiority of the SR towards the null. Thus, for patients in the FG group who did not return, we considered them to have high satisfaction and no major complications.


Enrollment: 138
Study Start Date: April 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shang Ring Guided Circumcision
The Shang Ring (SR) (Wuhu Santa Medical Devices Technology Co Ltd, China) male circumcision performed by study surgeon (study PI). In both study groups, participants were cleaned with povidone iodine solution and draped in a sterile fashion. Local anesthesia was administered to the dorsal penile nerve and penile ring blocks using 3mg/kg of 1% lidocaine. The surgeon measured participants in the SR group to determine ring size. Patients for whom a suitable ring size was not available crossed over to the FG group, but remained in the SR group for intention to treat (ITT) analyses.
Procedure: Shang Ring Guided Circumcision
Active Comparator: Forceps Guided Circumcision
Standard forceps guided adult male circumcision was performed. In both study groups, participants were cleaned with povidone iodine solution and draped in a sterile fashion. Local anesthesia was administered to the dorsal penile nerve and penile ring blocks using 3mg/kg of 1% lidocaine.
Procedure: Forceps Guided Circumcision

Detailed Description:

Male undergoing elective AMC were recruited from the surgical outpatient department of Mbarara Regional Referral Hospital, Uganda. Patient age, marital status, smoking history and motive to seek AMC were recorded for each participant.

The investigators performed block randomization by study day. Consenting participants selected an opaque envelope from a box for randomization to SR or FG groups. All AMC procedures were performed by a locally-trained surgeon who had performed over 100 prior FG procedures but who had no prior experience of the SR procedure.

A study surgeon performed all procedures in the hospital operating theatres. In both study groups, participants were cleaned with povidone iodine solution and draped in a sterile fashion. Local anesthesia was administered to the dorsal penile nerve and penile ring blocks using 3mg/kg of 1% lidocaine. The surgeon measured participants in the SR group to determine ring size. Patients for whom a suitable ring size was not available crossed over to the FG group, but remained in the SR group for intention to treat (ITT) analyses. An assistant measured operative time using a stopwatch. For the SR group, timing began as the ring began to be fitted, and ceased when the foreskin had been excised. For the FG group, timing began at the first incision and ceased when the final suture was completed. Patients were discharged on the day of procedure, provided with sterile gauze dressings, and informed to change them twice daily until the first follow-up appointment.

All pre- and post-operative assessments were performed by the lead investigator at one hour after the procedure, and on the 3rd, 7th, 14th and 21st post-operative days.

The investigators measured incidence rates of all outcomes and estimated relative risk for the SR versus FG groups by fitting Poisson regression models with robust errors. The investigators compared time to healing with Kaplan-Meier survival curves and measured for a difference between groups using the likelihood ratio test. All analyses were initially performed using ITT analysis, and were repeated with an as-treated analysis by reallocating the 7 participants who crossed into the FG group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • Greater than 18 years old
  • Desire for adult male circumcision
  • Presenting outpatient department of Mbarara Regional Referral Hospital
  • Provide written informed consent

Exclusion Criteria:

  • HIV infection
  • Chronic paraphimosis
  • Genital ulcers
  • Penile carcinoma
  • Filariasis
  • Xerotica obliterans
  • Balanitis
  • Glans-prepuce adhesions
  • Frenular scar tissue
  • Urethral anatomical abnormality such as hypospadias or epispadias
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757938

Locations
Uganda
Mbarara University of Science and Technology
Mbarara, Uganda
Sponsors and Collaborators
Mbarara University of Science and Technology
Investigators
Principal Investigator: Samuel Kanyago, MD Mbarara University of Scince and Technology
  More Information

Publications:
Responsible Party: Mbarara University of Science and Technology
ClinicalTrials.gov Identifier: NCT01757938     History of Changes
Other Study ID Numbers: MUST2012-1
Study First Received: December 19, 2012
Last Updated: December 28, 2012
Health Authority: Uganda: Research Ethics Committee

Keywords provided by Mbarara University of Science and Technology:
HIV
Prevention
Adult Male Circumcision
Uganda
Shang Ring

ClinicalTrials.gov processed this record on April 14, 2014