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

Urethral Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357080
• Other study ID #: Uro_Azhar_4_020
• Status: Completed
• Start date: July 15, 2020
• Est. completion date: August 29, 2020

Study information

• Verified date: April 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 29, 2020
• Est. primary completion date: August 15, 2020
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients with incomplete medical records or follow-up informations

Related Conditions & MeSH terms

• Constriction, Pathologic
• Recurrence
• Urethral Stricture

Intervention

Procedure:
• Urethroplasty
Augmentation Anterior Urethroplasty Using Dorsal Onlay Buccal Mucosal Graft

Locations

Country	Name	City	State
Egypt	Urology Department, Al-Azhar University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urethral restricture rate	The presence of radiologic and endoscopic features of urethral stricture recurrence, as diagnosed by urethrography and cystoscopy during follow-up.	At any time from date of surgery until the last follow-up visit (up to 10 years)
Primary	Time to urethral restricture.	will be calculated from the date of surgery until the date restricture diagnosis	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).