Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair

Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair: A Prospective Randomized Trial

This study aims to compare the surgical and functional outcomes of microsurgical single dartos flap versus double dartos flap in distal hypospadias repair.

Study Overview

• Status: Recruiting
• Conditions: Microsurgical; Single Dartos Flap; Double Dartos Flap; Distal Hypospadias Repair
• Intervention / Treatment: Procedure: Microsurgical Single Dartos Flap; Procedure: Microsurgical Double Dartos Flap

Detailed Description

Hypospadias is recognized as a frequent congenital defect of the male urogenital system, with its prevalence exhibiting significant regional and ethnic disparities globally.

Despite continuous improvements in surgical methodology, the development of a urethrocutaneous fistula (UCF) remains a persistent and difficult postoperative challenge. Reported UCF rates fluctuate between 1% and over 20%, heavily influenced by factors such as the initial position of the meatus, the specific surgical approach, and the practitioner's level of expertise.

Expanding on the use of a single-layer dartos flap (SDF), recent research has focused on whether a double-layer dartos flap (DDF) provides enhanced protection against fistula formation.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Goda, MBBCH; Phone Number: 00201146341100; Email: mamo.goda20@gmail.com

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Contact: Ahmed M Goda, MBBCH; Phone Number: 00201146341100; Email: mamo.goda20@gmail.com
      • Sub-Investigator: Mohamed R Taha, MD
      • Sub-Investigator: Osama M El-Gamal, MD
      • Sub-Investigator: Mohamed I El-Maadawy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male patients diagnosed with Distal Hypospadias.
• Age: From 6 months to 18 years.
• Primary cases.
• Uretheral Plate>8mm.
• Glanular width≥14mm.

Exclusion Criteria:

• Coronal and glanular hypospadias.
• Severe chordee.
• Associated disorders of sexual development.
• Un-controlled bleeding disorders.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients will undergo Microsurgical Single Dartos Flap.	Procedure: Microsurgical Single Dartos Flap; Patients will undergo Microsurgical Single Dartos Flap.
Experimental: Group B; Patients will undergo Microsurgical Double Dartos Flap.	Procedure: Microsurgical Double Dartos Flap; Patients will undergo Microsurgical Double Dartos Flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the Uethrocutaneous fistula	Incidence of the Uethrocutaneous fistula will be recorded.	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the meatal stenosis	Incidence of the meatal stenosis will be recorded.	6 months after surgery
Wound infection rate	Wound infection rate will be recorded.	6 months after surgery
Cosmetic appearance	Cosmetic appearance will be recorded.	6 months after surgery
Overall complication rate	Overall complication rate will be recorded.	6 months after surgery

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 36265MS61/5/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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