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

NCT04605068 | Completed DMC

• 1 other identifier: Al-Azhar Duckett's versus DFPF
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypospadias, Penoscrotal; Chordee

Keywords

Penoscrotal Hypospadias; Chordee; Tubularized Double-Faced Preputial Flap; Duckett's Urethroplasty; One-Stage Repair

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Penile rotation (number & percent)

  3 years

• Urine stream (in caliber)

  3 years

• Urine stream (in meters)

  3 years

• Micturition time (in seconds)

  3 years

• Follow-up period (in months)

  5 years

Study Arms (2)

Transverse preputial island flap (Duckett's technique)

ACTIVE COMPARATOR

72 patients (Group I) with penoscrotal hypospadias with chordee

Procedure: Transverse preputial island flap (Duckett's technique)

Double-faced preputial flap (DFPF)

ACTIVE COMPARATOR

72 patients (Group II) with penoscrotal hypospadias with chordee

Procedure: Double-faced preputial flap (DFPF)

Interventions

Transverse preputial island flap (Duckett's technique) PROCEDURE

Transverse preputial island flap (Duckett's technique)

Double-faced preputial flap (DFPF) PROCEDURE

Double-faced preputial flap (DFPF)

Eligibility Criteria

• Age: 6 Months - 14 Years
• Gender Eligibility Details: Male children with penoscrotal hypospadias with chordee
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Uncircumcised male patients with penoscrotal hypospadias,
• rudimentary urethral plate
• with moderate-to-severe chordee and
• no history of previous repair

You may not qualify if:

• 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.

Sponsors & Collaborators

• dr. Muhammad Abdelhafez Mahmoud, MD: lead

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mohamed M Shahin, MD

  Al-Azhar New Damietta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double masking (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of pediatric surgery

Model Details: 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).

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 27, 2020
• Study Start: March 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: March 2020 till indefinitely
• Access Criteria: after the article became accepted and available online.