Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics (DFOF#TIOF)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypospadias
• Intervention / Treatment: Procedure: Double faced transverse preputial onlay island flap; Procedure: Transverse inner preputial onlay island flap

Detailed Description

Type of study: prospective RCT

Review of literature:

• Different previous techniques for the repair of various levels of penile shaft hypospadias with chordee.
• Demonstration of two different well-established techniques for repair of anterior, mid-penile, and posterior penile hypospadias without or with mild curvature.
• Disadvantages of two-stage urethroplasty or technique as transverse inner preputial onlay island flap that involves dissection of the flap from its dorsal preputial tissue (as it affects the flap vascularity).
• Merits of single-stage urethroplasty double-faced preputial onlay island flap (as it combines the benefits of vascularized pedicled flap, provides better functional and cosmetic results, and low complication rate).

This study will be conducted at pediatric surgery department at Al-Houssain and Sayed Galal University Medical Centers, in the period from May 2019 to February 2021, on 68 male patients with anterior, mid-penile, and posterior penile hypospadias without or with mild curvature.

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 urethroplasty; double-faced preputial onlay island flap versus transverse inner preputial onlay island flap.

Written informed consent will be signed by the parents of all participants in the study.

Institutes of the study: A multicenter study at pediatric surgery departments, Al-Azhar University Medical Centers in Cairo, Egypt.

Number of cases: Sixty-eight male patients. Time frame: 3 years.

Ethical Consideration:

The protocol will be discussed and approved by the Ethics and Institutional Review Board Committee at the investigators' hospitals. The procedures and the aim of the study will be clearly explained to the patient and the family. Written informed consent will be obtained before enrollment of the patients into the study. The family's refusal to give consent for one-stage repair is respected but does not deprive the patient of 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, Urinalysis). Participants will receive a dose of single broad-spectrum antibiotic 30 min-1 hour before surgery.

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. All operations were done by the same surgical team.

Follow-up: patients will be followed-up at OPD at 1, 3, 12, and 24 months, for incidence of any complications. HOSE score questionnaire will be used for the evaluation of outcomes.

Statistical Analysis:

Data will be presented as mean, standard deviation, number & percentage. For qualitative data, Chi-square test (X2) is used to compare between the two groups and independent-samples t-test of significance is used when comparing between two means. The significance level is set at P <0.05. Statistical analysis will be performed using statistical package for social sciences (SPSS) version 23.0, IBM Corp, IBM SPSS Statistics for Windows, Armonk, NY, USA.

Discussion:

It will focus on one-stage repair for anterior, mid-penile, and posterior penile hypospadias without or with mild penile curvature using double-faced preputial onlay island flap in comparison to inner preputial onlay island flap.

The results obtained from this study will be compared between both groups and with those reported in the literature.

Also, it will focus on results, complications, their management, and clinical evaluation by Hypospadias Objective Scoring Evaluation (HOSE) questionnaire evaluation tool. Finally, the investigators will conclude the reconstructive technique that gives the better results and least morbidity.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11651
    • Mohammad Alsayed Daboos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Double faced transverse preputial onlay island flap (group A); Thirty-four patients undergo double faced transverse preputial onlay island flap are categorized as (group A)	Procedure: Double faced transverse preputial onlay island flap; A well-established one-stage repair of penile hypospadias called Double faced transverse preputial onlay island flap
ACTIVE_COMPARATOR: transverse inner preputial onlay island flap (control group) (group B); 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; A second well-established one-stage repair of penile hypospadias called Transverse inner preputial onlay island flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meatal location	Meatal location in number of cases	3 years
Meatal shape	Meatal shape in number of cases	3 years
Urinary stream direction	Urinary stream in number of cases	3 years
Erection	Erection straightness in number of cases	3 years
Fistula	Fistula in number of cases	3 years

Collaborators and Investigators

• Sponsor: dr. Muhammad Abdelhafez Mahmoud, MD
• Investigators: Study Chair: Khalid Abdelhaleem Hefney, MD, Pediatric Surgery Department, Al-Azhar University, Cairo, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): February 28, 2021

Study Registration Dates

• First Submitted: November 20, 2021
• First Submitted That Met QC Criteria: November 20, 2021
• First Posted (ACTUAL): December 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Double face;; Onlay island flap;; Inner preputial flap;; Hypospadias in pediatrics
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Hypospadias
• Other Study ID Numbers: Al-Azhar DFOF versus TIOF

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: November 2021 till indefinitely
• IPD Sharing Access Criteria: after the article became accepted and available online.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Study Data/Documents

1. Study Protocol
   Information identifier: orcid.org/0000-0002-6328-6419
   Information comments: Upon request of data, any researcher can e-mail the investigators at daboosmohammad@gmail.com or mohamedhafez_82@yahoo.com and the investigators will share the required data with the researchers and will be happy for any support.

Drug and device information, study documents

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