Clinical trial NCT04357080: Factors Predicting Urethral Stricture Recurrence After Dorsal Onlay Augmented, Buccal Mucosal Graft Urethroplasty
Official title: Factors Predicting Urethral Stricture Recurrence After Dorsal Onlay Augmented, Buccal Mucosal Graft Urethroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urethral Stricture
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 250
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent augmented anterior urethroplasty with buccal mucosal graft at Al-Azhar University Hospital in the past 10 years

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients with incomplete medical records or follow-up informations

Primary outcomes:
measure: urethral restricture rate
timeFrame: At any time from date of surgery until the last follow-up visit (up to 10 years)
measure: Time to urethral restricture.
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Urology Department, Al-Azhar University Hospital
Study officials:
References: