Effect of Adding Byar's Flap to Double Dartos Coverage in TIP Urethroplasty for Distal Hypospadias: A Randomized Trial (DD-TIP-BF)

April 6, 2026 updated by: Javaid Afridi

Double Dartos Versus Double Dartos Plus Byars' Flap in TIP Urethroplasty for Distal Hypospadias: A Randomized Controlled Trial

This randomized controlled trial evaluates the effect of adding Byar's flap in combination with double dartos flap coverage during tubularized incised plate (TIP) urethroplasty in children with distal hypospadias. The study compares surgical outcomes between two techniques: TIP urethroplasty with double dartos coverage alone versus TIP urethroplasty with double dartos plus Byar's flap reinforcement.

The primary outcome is the rate of postoperative complications, including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and wound infection. Secondary outcomes include cosmetic outcome assessment and functional results using validated scoring systems.

Patients diagnosed with distal penile hypospadias were randomly assigned to either surgical group. All procedures were performed by an experienced pediatric surgeon under standardized operative conditions. Follow-up assessments were conducted over a 6-month postoperative period to evaluate early and intermediate surgical outcomes.

The objective of this study is to determine whether the addition of Byar's flap provides superior surgical outcomes compared to standard double dartos coverage in TIP urethroplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypospadias is a common congenital anomaly of the male urethra requiring surgical correction, with tubularized incised plate (TIP) urethroplasty being one of the most widely used techniques for distal forms. Despite advances in surgical methods, postoperative complications such as urethrocutaneous fistula, glans dehiscence, and meatal stenosis remain clinically significant.

Various tissue interposition techniques have been introduced to reduce complication rates, including the use of dartos flaps for neourethral coverage. The double dartos flap technique provides additional vascularized tissue support and has been associated with improved outcomes. However, in some cases, reinforcement with additional vascularized tissue such as Byar's flaps may further enhance healing and reduce complications.

This study was designed as a prospective randomized controlled trial conducted at Mardan Medical Complex. Pediatric patients diagnosed with distal penile hypospadias were enrolled and randomly allocated into two groups. Group A underwent TIP urethroplasty with double dartos flap coverage, while Group B underwent TIP urethroplasty with double dartos flap combined with Byar's flap reinforcement. All surgeries were performed under standardized operative protocols by an experienced pediatric surgeon to minimize technical variability. Postoperative care was uniform across both groups. Patients were followed at regular intervals for a period of six months. The primary endpoint was the incidence of postoperative complications, including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and wound infection. Secondary endpoints included cosmetic outcome and functional assessment of urinary stream.

The aim of this study was to evaluate whether the addition of Byar's flap to standard double dartos coverage provides a statistically and clinically significant improvement in surgical outcomes following TIP urethroplasty in distal hypospadias.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Mardan, KPK, Pakistan, 22000
        • Mardan Medical Complex, Department of Pediatric Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Male children aged 2-12 years Diagnosis of primary distal penile hypospadias (glanular, coronal, or subcoronal) No previous surgical repair for hypospadias Fit for general anesthesia as determined by preoperative assessment Written informed consent provided by parents or legal guardians -

Exclusion Criteria:

Midshaft or proximal hypospadias Severe chordee requiring staged repair Previous penile or hypospadias surgery Associated major genital anomalies Micropenis Bleeding disorders or systemic coagulopathies Unfit for general anesthesia

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Double Dartos Flap Group
Participants in this group undergo tubularized incised plate (TIP) urethroplasty with double dartos flap coverage as a second-layer reinforcement over the neourethra for distal hypospadias repair.
Procedure: Double Dartos Flap Coverage
A vascularized dartos fascia flap is harvested and used as a second-layer coverage over the neourethra following tubularized incised plate (TIP) urethroplasty to reduce postoperative complications such as urethrocutaneous fistula.
Experimental: Double Dartos + Byar's Flap Group
Participants in this group undergo tubularized incised plate (TIP) urethroplasty with double dartos flap coverage combined with Byar's flap reinforcement to provide additional vascularized tissue support over the neourethra in distal hypospadias repair.
Procedure: Byar's Flap + Double Dartos Flap
Byar's flaps are created from preputial skin and combined with double dartos flap coverage to reinforce the neourethral repair after tubularized incised plate (TIP) urethroplasty in distal hypospadias.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urethrocutaneous Fistula Formation
Time Frame: 6 months postoperatively
Incidence of urethrocutaneous fistula following tubularized incised plate (TIP) urethroplasty in distal hypospadias repair. Patients were assessed during scheduled follow-up visits over 6 months. Fistula formation was confirmed by clinical examination during postoperative evaluation.
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOSE Score (Cosmetic and Functional Outcome)
Time Frame: 6 months postoperatively
Cosmetic and functional outcome was assessed using the Hypospadias Objective Scoring Evaluation (HOSE) system at 6-month follow-up. Scores were compared between both surgical groups.
6 months postoperatively
Parental Satisfaction Score
Time Frame: 6 months postoperatively
Parental satisfaction with surgical outcome was assessed using a standardized satisfaction scale at 6-month follow-up. Scores were analyzed between both groups.
6 months postoperatively
Operative Time
Time Frame: Intraoperative (during surgery)
Total operative time was recorded from skin incision to completion of wound closure in minutes for each surgical group.
Intraoperative (during surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javaid Afridi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Actual)

July 10, 2025

Study Completion (Actual)

July 10, 2025

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC-HYPOSPADIAS-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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