Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee (DuckettvDFPF)
Primary Purpose
Hypospadias, Penoscrotal, Chordee
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transverse preputial island flap (Duckett's technique)
Double-faced preputial flap (DFPF)
Sponsored by
About this trial
This is an interventional treatment trial for Hypospadias, Penoscrotal focused on measuring Penoscrotal Hypospadias, Chordee, Tubularized Double-Faced Preputial Flap, Duckett's Urethroplasty, One-Stage Repair
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transverse preputial island flap (Duckett's technique)
Double-faced preputial flap (DFPF)
Arm Description
72 patients (Group I) with penoscrotal hypospadias with chordee
72 patients (Group II) with penoscrotal hypospadias with chordee
Outcomes
Primary Outcome Measures
Urethrocutaneous fistula (number & percent)
Urethrocutaneous fistula
Meatal stenosis (number & percent)
Meatal stenosis
Urethral stricture (number & percent)
Urethral stricture
Secondary Outcome Measures
Penile rotation (number & percent)
Penile rotation
Urine stream (in caliber)
Urine stream
Urine stream (in meters)
Urine stream
Micturition time (in seconds)
Micturition time
Follow-up period (in months)
Follow-up period
Full Information
NCT ID
NCT04605068
First Posted
October 9, 2020
Last Updated
October 21, 2020
Sponsor
dr. Muhammad Abdelhafez Mahmoud, MD
1. Study Identification
Unique Protocol Identification Number
NCT04605068
Brief Title
Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee
Acronym
DuckettvDFPF
Official Title
Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
dr. Muhammad Abdelhafez Mahmoud, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Ethical Consideration:
The protocol will be discussed and approved for clinical study by the Ethical Research Committee at the principal investigator's hospital. The procedures and the aim of the study will be clearly explained to the patient and the family. A written informed consent will be obtained before enrollment of the patients into the study. The family refusal to give consent for one-stage repair is respected but does not deprive the patient from getting surgical care by two-stage repair.
Preoperative preparation:
All patients will be subjected to history taking, clinical examination, and necessary laboratory investigations (CBC, Coagulation profile, Liver and Renal Function tests, Electrolytes Panel, Urinalysis). They will receive a dose of single broad-spectrum antibiotic 30 min-1 hour before surgery. Patients will be randomly divided (using the computer-generated randomization table) into two equal groups, each will include 72 patients; Group I will undergo transverse preputial island flap (Duckett's technique) and Group II will undergo double-faced preputial flap (DFPF). Both techniques will be done by all members of the surgical team equally.
Follow-up:
Patients will be followed-up at OPD.
Statistical Analysis:
Data were collected using a data collecting sheets (annexes) and were analyzed using the statistical package for social sciences (SPSS) version 24.0 (IBM SPSS Statistics for Windows, IBM Corp, Armonk, NY, USA). Continuous variables were expressed as mean±standard deviation (SD), range, and average and categorical variables were expressed as frequency count & percentage. Fisher's exact test was used for comparison of frequency counts/percentage. A two-sided p-value < 0.05 was considered statistically significant.
Discussion:
It will focus on one-stage urethroplasty using the preputial flap for proximal hypospadias with chordee. The results obtained from this study will be compared between both group and with those reported in the literature.
Also, it will focus on results, complications, their management, and clinical evaluation by estimated urine caliber and micturition time. At the end, the investigators will conclude the reconstructive technique that gives the better results and least morbidity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias, Penoscrotal, Chordee
Keywords
Penoscrotal Hypospadias, Chordee, Tubularized Double-Faced Preputial Flap, Duckett's Urethroplasty, One-Stage Repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
144 patients will be randomly divided (using the computer-generated randomization table) into two equal groups, each will include 72 patients; Group I will undergo transverse preputial island flap (Duckett's technique) and Group II will undergo double-faced preputial flap (DFPF).
Masking
ParticipantInvestigator
Masking Description
Double masking (Participant, Investigator)
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transverse preputial island flap (Duckett's technique)
Arm Type
Active Comparator
Arm Description
72 patients (Group I) with penoscrotal hypospadias with chordee
Arm Title
Double-faced preputial flap (DFPF)
Arm Type
Active Comparator
Arm Description
72 patients (Group II) with penoscrotal hypospadias with chordee
Intervention Type
Procedure
Intervention Name(s)
Transverse preputial island flap (Duckett's technique)
Intervention Type
Procedure
Intervention Name(s)
Double-faced preputial flap (DFPF)
Primary Outcome Measure Information:
Title
Urethrocutaneous fistula (number & percent)
Description
Urethrocutaneous fistula
Time Frame
2 years
Title
Meatal stenosis (number & percent)
Description
Meatal stenosis
Time Frame
2 years
Title
Urethral stricture (number & percent)
Description
Urethral stricture
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Penile rotation (number & percent)
Description
Penile rotation
Time Frame
3 years
Title
Urine stream (in caliber)
Description
Urine stream
Time Frame
3 years
Title
Urine stream (in meters)
Description
Urine stream
Time Frame
3 years
Title
Micturition time (in seconds)
Description
Micturition time
Time Frame
3 years
Title
Follow-up period (in months)
Description
Follow-up period
Time Frame
5 years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male children with penoscrotal hypospadias with chordee
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Shahin, MD
Organizational Affiliation
Al-Azhar New Damietta University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study will add to the literature
IPD Sharing Time Frame
March 2020 till indefinitely
IPD Sharing Access Criteria
after the article became accepted and available online.
Learn more about this trial
Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee
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