Redo Repair in Disrupted Hypospadias

NCT06187363 | Completed

• 1 other identifier: 0306287
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Hypospadias

Keywords

Hypospadias; Redo repair; Disruption

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Patients managed by tubularized incised plate procedure

Patients with redo hypospadias repair using tubularized incised plate procedure

Procedure: Tubularized incised plate procedure

Patients treated by procedures other than tubularized incised plate procedure

Patients with redo hypospadias repair using other procedures

Procedure: Other procedures

Interventions

Tubularized incised plate procedure PROCEDURE

Tubularized incised plate urethroplasty procedure

Patients managed by tubularized incised plate procedure

Other procedures PROCEDURE

Other procedures than tubularized incised plate urethroplasty procedure

Patients treated by procedures other than tubularized incised plate procedure

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Pediatric patients with disrupted hypospadias repair

You may not qualify if:

• Fresh cases of hypospadias

Sponsors & Collaborators

• Egyptian Biomedical Research Network: lead

Study Sites (1)

Faculty of Medicine

Alexandria, 12345, Egypt

Location

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ahmed Elrouby, MD

  Pediatric Surgery department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of pediatric Surgery

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: January 2, 2024
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)