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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06187363
Other study ID # 0306287
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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