Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias
Sponsor
Al-Azhar University (Other)
Overall Status
Completed
CT.gov ID
NCT05960123
Collaborator
(none)
220
1
2
49.9
4.4
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias
Actual Study Start Date
:
Apr 1, 2019
Actual Primary Completion Date
:
Jan 1, 2023
Actual Study Completion Date
:
May 30, 2023
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Urethrocutaneous fistula [12 months]
Rate of fistula
- meatal stenosis [12 months]
Rate of metal stenosis
- glans dehiscence [12 months]
Rate of glans dehiscence
Other Outcome Measures
- Cosmetic results [12 months]
Hypospadias Objective Scoring Evaluation (maximum the best is 16 points ) and minimum the worst is 4
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 14 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mohammad Daboos | Cairo | Select | Egypt | 115678 |
Sponsors and Collaborators
- Al-Azhar University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mohammad Daboos,
Professor of pediatric surgery,
Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05960123
Other Study ID Numbers:
- IRB 0000395-24-01-019
First Posted:
Jul 25, 2023
Last Update Posted:
Jul 25, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohammad Daboos,
Professor of pediatric surgery,
Al-Azhar University
Additional relevant MeSH terms: