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

Primary Purpose

Hypospadias, Complication,Postoperative

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tubularized Incised Plate (TIP) urethroplasty
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypospadias focused on measuring Distal and midpenile hypospadias, TIPU, Spongioplasty-dartosoraphy, pediatric HOSE

Eligibility Criteria

6 Months - 14 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mohammad Daboos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group with Spongioplasty

Group without Spongioplasty

Arm Description

patients underwent TIPU with spongioplasty-Dartosoraphy reinforcement

patients underwent TIPU with dorsal dartos flap interposition without spongioplasty

Outcomes

Primary Outcome Measures

Urethrocutaneous fistula
Rate of fistula
meatal stenosis
Rate of metal stenosis
glans dehiscence
Rate of glans dehiscence

Secondary Outcome Measures

Full Information

First Posted
July 10, 2023
Last Updated
July 21, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05960123
Brief Title
Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias
Official Title
Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias, Complication,Postoperative
Keywords
Distal and midpenile hypospadias, TIPU, Spongioplasty-dartosoraphy, pediatric HOSE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group with Spongioplasty
Arm Type
Active Comparator
Arm Description
patients underwent TIPU with spongioplasty-Dartosoraphy reinforcement
Arm Title
Group without Spongioplasty
Arm Type
Active Comparator
Arm Description
patients underwent TIPU with dorsal dartos flap interposition without spongioplasty
Intervention Type
Procedure
Intervention Name(s)
Tubularized Incised Plate (TIP) urethroplasty
Intervention Description
tubularization of urethral plate with or without spongioplasty
Primary Outcome Measure Information:
Title
Urethrocutaneous fistula
Description
Rate of fistula
Time Frame
12 months
Title
meatal stenosis
Description
Rate of metal stenosis
Time Frame
12 months
Title
glans dehiscence
Description
Rate of glans dehiscence
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Cosmetic results
Description
Hypospadias Objective Scoring Evaluation (maximum the best is 16 points ) and minimum the worst is 4
Time Frame
12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
this anomalies of male genitalia
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mohammad Daboos
City
Cairo
State/Province
Select
ZIP/Postal Code
115678
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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