Redo Repair in Disrupted Hypospadias

Hypospadias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06187363
• Other study ID #: 0306287
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2024
• Source: Egyptian Biomedical Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pediatric patients with disrupted hypospadias repair

Exclusion Criteria:

• Fresh cases of hypospadias

Related Conditions & MeSH terms

• Hypospadias

Intervention

Procedure:
• Tubularized incised plate procedure
Tubularized incised plate urethroplasty procedure
• Other procedures
Other procedures than tubularized incised plate urethroplasty procedure

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Biomedical Research Network

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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