Redo Repair in Disrupted Hypospadias

Completed

• Conditions: Hypospadias
• Interventions: Procedure: Other procedures; Procedure: Tubularized incised plate procedure

• Registration Number: NCT06187363
• Lead Sponsor: Egyptian Biomedical Research Network

Brief Summary

Redo hypospadias repair is a challenging situation and its success depends on many factors. Several procedures could be used in such situations with variable outcomes. The investigator in this study aimed at comparing the results of these procedures

Detailed Description

Purpose: Our study compared the outcome of the tubularized incised plate urethroplasty procedure and other procedures in the case of redo hypospadias repair. Methods: The participants were categorized into those who were treated by the tubularized incised plate procedure (Group A) and those who were treated by other procedures (Group B) and the collected data were compared between the two groups. The patients were examined regularly during the postoperative period for urethral-cutaneous fistula, meatal stenosis, penile curvature, penile skin coverage, and re-disruption.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-12-16
• Study First Posted: 2024-01-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Pediatric patients with disrupted hypospadias repair

Exclusion Criteria

• Fresh cases of hypospadias

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated by procedures other than tubularized incised plate procedure	Other procedures	Patients with redo hypospadias repair using other procedures
Patients managed by tubularized incised plate procedure	Tubularized incised plate procedure	Patients with redo hypospadias repair using tubularized incised plate procedure

Primary Outcome Measures

Name	Time	Method
The number of participants who developed post-operative meatal stricture	at 1 month, 3 months, 6 months, and at the end of the 1st year	assessment of the position of neo-meatus in glans together with its diameter as well as the presence of stenosis as judged by urethral calibration
The rate of development of recurrent post-operative chordae	at 1 month, 3 months, 6 months, and at the end of the 1st year	The recurrence of ventral penile chordae as discovered by recurrent ventral penile curvature
The incidence of development of postoperative penile skin scarring	at 1 month, 3 months, 6 months, and at the end of the 1st year	Assessment of penile skin coverage as judged by the development of recurrent curvature, torsion and/or disfigurement
The incidence of the development of failed repair as discovered by the position of the neo-meatus	at 1 month, 3 months, 6 months, and at the end of the 1st year	Re-disruption the reposition of the neo-meatus to the previous site
The incidence of the development of post-operative urethral-cutaneous fistula	at 1 month, 3 months, 6 months, and at the end of the 1st year	The development of post-operative urethral-cutaneous fistula as judged by the development of a second urethral openning proximal to the neo-meatus

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt