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

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ClinicalTrials.gov Identifier: NCT01757938
Recruitment Status : Completed
First Posted : December 31, 2012
Last Update Posted : December 31, 2012
Sponsor:
Information provided by (Responsible Party):
Mbarara University of Science and Technology

Tracking Information
First Submitted Date  ICMJE December 19, 2012
First Posted Date  ICMJE December 31, 2012
Last Update Posted Date December 31, 2012
Study Start Date  ICMJE April 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2012)
  • Procedure Time [ Time Frame: 21 days ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2012)
  • Pain [ Time Frame: 21 days ]
    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 ]
    Self-reported time to resumption of normal activity (defined as attendance at university classes)
  • Patient Satisfaction [ Time Frame: 21 days ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Control Trial of Shang Ring Versus Forceps-guided Adult Male Circumcision in Southwestern Uganda.
Official Title  ICMJE Shang Ring Versus Forceps-guided Adult Male Circumcision: a Randomized Controlled Effectiveness Study in Southwestern Uganda.
Brief Summary 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.
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.

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 HIV
Intervention  ICMJE
  • Procedure: Shang Ring Guided Circumcision
  • Procedure: Forceps Guided Circumcision
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Procedure: Forceps Guided Circumcision
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: December 28, 2012)
138
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01757938
Other Study ID Numbers  ICMJE MUST2012-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mbarara University of Science and Technology
Study Sponsor  ICMJE Mbarara University of Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Samuel Kanyago, MD Mbarara University of Scince and Technology
PRS Account Mbarara University of Science and Technology
Verification Date December 2012

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