Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics

NCT05144659 | Completed DMC

• 1 other identifier: Al-Azhar DFOF versus TIOF
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of double faced transverse preputial onlay island flap for hypospadias repair in pediatrics. The preputial onlay island flap technique has been popularized for hypospadias repair as a result of offering a consistent combination of excellent cosmetic results and acceptable complication rates. Like other techniques, urethrocutaneous fistulae continue to be the most common complications, in addition to other complications, and can be attributed to the affection of flaps vascularity. Some authors describe a technique that resolves some of these problems by combining the unique benefits of the double-faced preputial flaps. This study aimed to evaluate double faced preputial onlay island flap technique for complication rate, outcomes for urinary stream, and cosmetic results.

Conditions

Hypospadias

Keywords

Double face;; Onlay island flap;; Inner preputial flap;; Hypospadias in pediatrics

Outcome Measures

Primary Outcomes (5)

• Urethrocutaneous fistula

  Urethrocutaneous fistula in number of cases \&percentage

  3 years

• Flap necrosis

  Flap necrosis in number of cases \&percentage

  3 years

• Glannular dehiscence

  Glannular dehiscence in number of cases \&percentage

  3 years

• Penile rotation

  Penile rotation in number of cases \&percentage

  3 years

• Urethral diverticulum

  Urethral diverticulum in number of cases \&percentage

  3 years

Secondary Outcomes (5)

• Meatal location

  3 years

• Meatal shape

  3 years

• Urinary stream direction

  3 years

• Erection

  3 years

• Fistula

  3 years

Study Arms (2)

Double faced transverse preputial onlay island flap (group A)

ACTIVE COMPARATOR

Thirty-four patients undergo double faced transverse preputial onlay island flap are categorized as (group A)

Procedure: Double faced transverse preputial onlay island flap

transverse inner preputial onlay island flap (control group) (group B)

ACTIVE COMPARATOR

Another thirty-four patients undergo transverse inner preputial onlay island flap are categorized as the control group = (group B)

Procedure: Transverse inner preputial onlay island flap

Interventions

Double faced transverse preputial onlay island flap PROCEDURE

A well-established one-stage repair of penile hypospadias called Double faced transverse preputial onlay island flap

Double faced transverse preputial onlay island flap (group A)

Transverse inner preputial onlay island flap PROCEDURE

A second well-established one-stage repair of penile hypospadias called Transverse inner preputial onlay island flap

transverse inner preputial onlay island flap (control group) (group B)

Eligibility Criteria

• Age: 1 Year - 14 Years
• Gender Eligibility Details: Male children with anterior, mid-penile, and posterior penile hypospadias without or with mild penile curvature
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Young male pediatric patients diagnosed as anterior, mid-penile, or posterior penile hypospadias
• with shallow and narrow urethral plate measuring less than 6 millimeters,
• without or with mild penile curvature of less than 30º after degloving of the penis.

You may not qualify if:

• Patients with wide urethral plate suitable for tubularized incised plate (TIP) urethroplasty,
• other types of hypospadias as penoscrotal, scrotal, perineal hypospadias,
• patients with moderate or severe penile curvature,
• recurrent cases, and
• operations done by other surgeons

Sponsors & Collaborators

• dr. Muhammad Abdelhafez Mahmoud, MD: lead

Study Sites (1)

Mohammad Alsayed Daboos

Cairo, 11651, Egypt

Location

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

• Khalid Abdelhaleem Hefney, MD

  Pediatric Surgery Department, Al-Azhar University, Cairo, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 2 (Participant, Investigator) 2 masking (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of pediatric surgery, Faculty of Medicine, Al-Azhar University

Model Details: 68 pediatric patients will be randomly divided (using non-transparent closed envelope randomization method) into two equal groups, each will include 34 patients; Group A will undergo double-faced preputial onlay island flap and Group B will undergo transverse inner preputial onlay island flap.

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: December 3, 2021
• Study Start: May 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: February 28, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: November 2021 till indefinitely
• Access Criteria: after the article became accepted and available online.

Locations

EG (1)