Modified Second Layer Repair for Distal Penile Hypospadias

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05253456

Collaborator

(none)

102

Enrollment

Location

Arm

30.1

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

to evaluate a modification to snodgrass technique in second layer closure of distal penile hypospadias

Condition or Disease	Intervention/Treatment	Phase
Hypospadias	Procedure: Derma -Dartos Flap for second layer closure	Phase 2

Detailed Description

In our study, we applied a new modification by using an intervening layer of a de-epithelialized ventral derma-dartos flap for neourethral covering. we present our newly applied technique and its impact on the success rate.

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Modified Tubularized Incised Plate Urethroplasty (Snodgrass) For Distal Hypospadias Repair in a Circumcised Patient With the Use of a Derma -Dartos Flap for Second Layer Closure: Our Initial Experience

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Sep 1, 2020

Actual Study Completion Date :

Sep 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention group patients underwent our newly modified technique for hypospadias repair	Procedure: Derma -Dartos Flap for second layer closure usage of Derma -Dartos Flap for second layer closure of a distal penile hypospadias in circumcised patients

Arm

Intervention/Treatment

Experimental: intervention group

patients underwent our newly modified technique for hypospadias repair

Procedure: Derma -Dartos Flap for second layer closure

usage of Derma -Dartos Flap for second layer closure of a distal penile hypospadias in circumcised patients

Outcome Measures

Primary Outcome Measures

urethro-cutaneous fistula [1 year follow up]
presence of urethro-cutaneous fistula after closure of hypospadias as assess by inspection for the presence of urinary fistula

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

All male patient with distal penile hypospadias aged less than 18

Exclusion Criteria:

Patients with penile rotation or hypoplastic urethral plate were excluded from the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Maher	Cairo	القاهرة	Egypt	11757

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Maher Gamil Ahmed Higazy, Assistant lecturer, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05253456

Other Study ID Numbers:

R22/2018

First Posted:

Feb 23, 2022

Last Update Posted:

Feb 23, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypospadias

Study Results

No Results Posted as of Feb 23, 2022