Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 144
- Primary Endpoint
- Urethrocutaneous fistula (number & percent)
Study Overview
Brief Summary
The purpose of this study is to compare the outcomes and complications of the transverse preputial island flap (Duckett's procedure) to those of double-faced preputial flap (DFPF) for one-stage repair of penoscrotal hypospadias with chordee, in addition to clinical functional evaluation by estimated urine flow.
Detailed Description
Type of study: RCT
Review of literature:
- Different modalities of urethroplasty for repair of proximal hypospadias with chordee (two-stage repair, one-stage repair, flap, graft).
- Disadvantages of two-stage urethroplasty for proximal hypospadias with chordee..
- Merits of one-stage urethroplasty for proximal hypospadias with chordee. This is a prospective randomized controlled study conducted at pediatric surgery department, Al-Houssain & New Damietta Al-Azhar University Hospitals, from March 2014 to March 2020, on 144 male patients with penoscrotal hypospadias with chordee. Patients will be investigated by routine laboratory tests for fitness for surgery. All of them will undergo one-stage repair using either of 2 techniques of tubularized preputial flap; Duckett's versus DFPF. Written informed consent will be obtained from parents of all participants in the study.
Institutes of the study:
A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals in Cairo and New Damietta. Number of cases: One-hundred-Forty four male patients. Time frame: period of 6 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Double masking (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Months to 14 Years (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Uncircumcised male patients with penoscrotal hypospadias,
- •rudimentary urethral plate
- •with moderate-to-severe chordee and
- •no history of previous repair
Exclusion Criteria
- •circumcised patients,
- •patients with other types of hypospadias such as glanular or distal shaft or
- •with mild chordee corrected after penile degloving,
- •recurrent hypospadias, or
- •lost to follow-up.
Outcomes
Primary Outcomes
Urethrocutaneous fistula (number & percent)
Time Frame: 2 years
Urethrocutaneous fistula
Meatal stenosis (number & percent)
Time Frame: 2 years
Meatal stenosis
Urethral stricture (number & percent)
Time Frame: 3 years
Urethral stricture
Secondary Outcomes
- Follow-up period (in months)(5 years)
- Penile rotation (number & percent)(3 years)
- Urine stream (in caliber)(3 years)
- Urine stream (in meters)(3 years)
- Micturition time (in seconds)(3 years)
Investigators
dr. Muhammad Abdelhafez Mahmoud, MD
Lecturer of pediatric surgery
Al-Azhar University