Factors Predicting Urethral Stricture Recurrence After Dorsal Onlay Augmented, Buccal Mucosal Graft Urethroplasty

Completed

• Conditions: Urethral Stricture
• Interventions: Procedure: Urethroplasty

• Registration Number: NCT04357080
• Lead Sponsor: Al-Azhar University

Brief Summary

In this observational study, the investigators will evaluate potential risk factors associated with urethral stricture recurrence after augmentation anterior urethroplasty using dorsal onlay buccal mucosal Graft during the past 10 years. Patients' medical files will be reviewed for data relevant to demographics, clinical and operative characteristics. data will be analyzed using the appropriate statistical tests and the independent predictors of urethroplasty outcome will be identified.

Detailed Description

In this series, the investigators will study different factors related to the stricture and to the patients to identify the independent predictors of urethral stricture recurrence after augmentation anterior urethroplasty using dorsal onlay buccal mucosal graft.

A retrospective review of medical records will be performed to identify patients who underwent augmented anastomotic anterior urethroplasty with dorsal onlay graft at Al-Azhar University Hospitals in Egypt since 2010. Patients will be included only if they were two or more years out of surgery. The data will be recorded without patients' identification.

Data to be collected are patient age, body mass index (BMI), smoking status, diabetes status, overall comorbidity, stricture etiology, prior endoscopic treatment and open urethroplasty, urethral stricture length and location, degree of urethral obliteration, urethral plate width, presence and degree of spongiofibrosis. estimated intraoperative blood loss, catheter size, overall operative time, hospital stay and early postoperative complications.

The diagnosis of urethral stricture recurrence is based on the radiological and endoscopic features of stricture recurrence. Time to recurrence will be calculated from the date of surgery till the date restricture diagnosis.

Univariate and multivariate regression analysis will be performed and factors predicting urethral stricture recurrence will be identified.

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-22
• Study Start: 2020-07-15
• Primary Completion: 2020-08-15
• Study Completion: 2020-08-29
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 250

Inclusion Criteria

• patients who will be 2 years or more out of surgery

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Exclusion Criteria

• patients with incomplete medical records or follow-up informations

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Urethroplasty	Patients with normal, patent urethra
Case	Urethroplasty	Patients with urethral stricture recurrence

Primary Outcome Measures

Name	Time	Method
urethral restricture rate	At any time from date of surgery until the last follow-up visit (up to 10 years)	The presence of radiologic and endoscopic features of urethral stricture recurrence, as diagnosed by urethrography and cystoscopy during follow-up.
Time to urethral restricture.	The time from urethroplasty surgery until the time of urethral restricure diagnosis (at any follow-up time point, up to 10 years), as recorded in patients medical files).	will be calculated from the date of surgery until the date restricture diagnosis

Trial Locations

Locations (1)

Urology Department, Al-Azhar University Hospital; 🇪🇬 Cairo, Egypt