The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
Sponsor
Mansoura University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05123833
Collaborator
(none)
88
1
2
12
7.3
Study Details
Study Description
Brief Summary
To explore the optimal urethral coverage in hypospadias repair by comparing the success rate of both covering techniques: Dartos fascia versus Tunica Vaginalis flap.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Optimal Urethral Coverage in Hypospadias Repair: Dartos Fascia Versus Tunica Vaginalis Flap? A Randomized Controlled Trial
Actual Study Start Date
:
Aug 1, 2021
Anticipated Primary Completion Date
:
Aug 1, 2022
Anticipated Study Completion Date
:
Aug 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dartos Fascia Dartos flap is used as a covering layer for urethra during repair of hypospadias |
Procedure: Hypospadias repair
surgical repair of hypospadias
|
| Active Comparator: Tunica Vaginalis Tunica Vaginalis Flap is used as a covering layer for urethra during repair of hypospadias |
Procedure: Hypospadias repair
surgical repair of hypospadias
|
Outcome Measures
Primary Outcome Measures
- Fistula [Within the first three months after surgery.]
Fistula prevalence will be recorded as a complication after surgery
Secondary Outcome Measures
- Cosmetic outcome [Within the first three months after surgery.]
Patients' parents reported cosmetic outcomes will be evaluated using The Pediatric Penile Perception Score (PPPS).
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 12 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Age ≥ 6 months.
-
Distal, mid-shaft penile hypospadias.
Exclusion Criteria:
-
Glanular hypospadias.
-
Penoscrotal, Scrotal & Perineal hypospadias.
-
Recurrent cases.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Urology and Nephrology Center, Mansoura University | Mansoura | Dakahlia | Egypt | 35516 |
Sponsors and Collaborators
- Mansoura University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT05123833
Other Study ID Numbers:
- Hypospadias-UC
First Posted:
Nov 17, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
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 Mansoura University
Additional relevant MeSH terms: