MicrosurgicalNCT07676916

Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair

A study testing Microsurgical Single Dartos Flap and Microsurgical Double Dartos Flap in people with Microsurgical and Single Dartos Flap, run by Tanta University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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

Who is it for?: Ages 6 months to 18 years
Conditions the study is for: Microsurgical, Single Dartos Flap, Double Dartos Flap
What is being tested?: Microsurgical Single Dartos Flap and Microsurgical Double Dartos Flap
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteEgypt
Study dates: 16 May 2026to 1 Apr 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmed M Goda, MBBCH contact

00201146341100

mamo.goda20@gmail.com

Egypt1 site, 1 recruiting

Tanta University
Tanta, El-Gharbia, 31527
Ahmed M Goda, MBBCH, 00201146341100, mamo.goda20@gmail.com
Mohamed R Taha, MD
Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Conditions: Microsurgical, Single Dartos Flap, Double Dartos Flap, Distal Hypospadias Repair
Being tested: Microsurgical Single Dartos Flap, Microsurgical Double Dartos Flap

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Microsurgical Single Dartos FlapProcedure or surgery
Patients will undergo Microsurgical Single Dartos Flap.
Microsurgical Double Dartos FlapProcedure or surgery
Patients will undergo Microsurgical Double Dartos Flap.

Study groups in NCT07676916
Study group	Role	What they receive
Group A	Experimental	Patients will undergo Microsurgical Single Dartos Flap. Receives: Procedure: Microsurgical Single Dartos Flap
Group B	Experimental	Patients will undergo Microsurgical Double Dartos Flap. Receives: Procedure: Microsurgical Double Dartos Flap

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of the Uethrocutaneous fistula
Incidence of the Uethrocutaneous fistula will be recorded.
Measured: 6 months after surgery

Secondary outcomes (4)

Incidence of the meatal stenosis
Incidence of the meatal stenosis will be recorded.
Measured: 6 months after surgery
Wound infection rate
Wound infection rate will be recorded.
Measured: 6 months after surgery
Cosmetic appearance
Cosmetic appearance will be recorded.
Measured: 6 months after surgery
Overall complication rate
Overall complication rate will be recorded.
Measured: 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 20261 Apr 2027

First posted30 Jun 2026
Study start16 May 2026
Primary completion1 Apr 2027 (estimated)
Study completion1 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MicrosurgicalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07676916
Sponsor's protocol ID: 36265MS61/5/26
Status last verified: Jun 2026
First submitted: 24 Jun 2026
Last updated: 30 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.