Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias

July 21, 2023 updated by: Mohammad Daboos, Al-Azhar University
The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

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

  • Egypt
    • Select
      • Cairo, Select, Egypt, 115678
        • Mohammad Daboos

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:

  • lees than 14 years Distal hypospadias urethral plate size more than 6mm glans size more than 14 mm

Exclusion Criteria:

  • recurrent cases Proximal; hypospadias

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group with Spongioplasty
patients underwent TIPU with spongioplasty-Dartosoraphy reinforcement
Procedure: Tubularized Incised Plate (TIP) urethroplasty
tubularization of urethral plate with or without spongioplasty
Active Comparator: Group without Spongioplasty
patients underwent TIPU with dorsal dartos flap interposition without spongioplasty
Procedure: Tubularized Incised Plate (TIP) urethroplasty
tubularization of urethral plate with or without spongioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urethrocutaneous fistula
Time Frame: 12 months
Rate of fistula
12 months
meatal stenosis
Time Frame: 12 months
Rate of metal stenosis
12 months
glans dehiscence
Time Frame: 12 months
Rate of glans dehiscence
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic results
Time Frame: 12 months
Hypospadias Objective Scoring Evaluation (maximum the best is 16 points ) and minimum the worst is 4
12 months

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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)

April 1, 2019

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 0000395-24-01-019

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.

Clinical Trials on Complication,Postoperative

Clinical Trials on Tubularized Incised Plate (TIP) urethroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe