Redo Repair in Disrupted Hypospadias

Tubularized Incised Plate (TIP) Procedure Versus Other Procedures in the Repair of Disrupted Hypospadias

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

Study Overview

• Status: Completed
• Conditions: Hypospadias
• Intervention / Treatment: Procedure: Tubularized incised plate procedure; Procedure: Other 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 12345
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Fifty patients were included in our study; all of them have disrupted repair of hypospadias. Half of those patients were treated by TIP procedure and the other half were treated by other procedures

Description

Inclusion Criteria:

• Pediatric patients with disrupted hypospadias repair

Exclusion Criteria:

• Fresh cases of hypospadias

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients managed by tubularized incised plate procedure; Patients with redo hypospadias repair using tubularized incised plate procedure	Procedure: Tubularized incised plate procedure; Tubularized incised plate urethroplasty procedure
Patients treated by procedures other than tubularized incised plate procedure; Patients with redo hypospadias repair using other procedures	Procedure: Other procedures; Other procedures than tubularized incised plate urethroplasty procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants who developed post-operative meatal stricture	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	at 1 month, 3 months, 6 months, and at the end of the 1st year
The rate of development of recurrent post-operative chordae	The recurrence of ventral penile chordae as discovered by recurrent ventral penile curvature	at 1 month, 3 months, 6 months, and at the end of the 1st year
The incidence of development of postoperative penile skin scarring	Assessment of penile skin coverage as judged by the development of recurrent curvature, torsion and/or disfigurement	at 1 month, 3 months, 6 months, and at the end of the 1st year
The incidence of the development of failed repair as discovered by the position of the neo-meatus	Re-disruption the reposition of the neo-meatus to the previous site	at 1 month, 3 months, 6 months, and at the end of the 1st year
The incidence of the development of post-operative urethral-cutaneous fistula	The development of post-operative urethral-cutaneous fistula as judged by the development of a second urethral openning proximal to the neo-meatus	at 1 month, 3 months, 6 months, and at the end of the 1st year

Collaborators and Investigators

• Sponsor: Egyptian Biomedical Research Network
• Investigators: Principal Investigator: Ahmed Elrouby, MD, Pediatric Surgery department

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hypospadias; Disruption; Redo repair
• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Hypospadias
• Other Study ID Numbers: 0306287

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