Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee (DuckettvDFPF)

Transverse Preputial Island Flap Versus Double Faced Preputial Flap for Repair of Penoscrotal Hypospadias With Chordee: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Chordee; Hypospadias, Penoscrotal
• Intervention / Treatment: Procedure: Transverse preputial island flap (Duckett's technique); Procedure: Double-faced preputial flap (DFPF)

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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transverse preputial island flap (Duckett's technique); 72 patients (Group I) with penoscrotal hypospadias with chordee	Procedure: Transverse preputial island flap (Duckett's technique)
Active Comparator: Double-faced preputial flap (DFPF); 72 patients (Group II) with penoscrotal hypospadias with chordee	Procedure: Double-faced preputial flap (DFPF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urethrocutaneous fistula (number & percent)	Urethrocutaneous fistula	2 years
Meatal stenosis (number & percent)	Meatal stenosis	2 years
Urethral stricture (number & percent)	Urethral stricture	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penile rotation (number & percent)	Penile rotation	3 years
Urine stream (in caliber)	Urine stream	3 years
Urine stream (in meters)	Urine stream	3 years
Micturition time (in seconds)	Micturition time	3 years
Follow-up period (in months)	Follow-up period	5 years

Collaborators and Investigators

• Sponsor: dr. Muhammad Abdelhafez Mahmoud, MD
• Investigators: Principal Investigator: Mohamed M Shahin, MD, Al-Azhar New Damietta University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Penoscrotal Hypospadias; Chordee; Tubularized Double-Faced Preputial Flap; Duckett's Urethroplasty; One-Stage Repair
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Hypospadias
• Other Study ID Numbers: Al-Azhar Duckett's versus DFPF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No