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

Sponsor
Al-Azhar University (Other)
Overall Status
Completed
CT.gov ID
NCT04357080
Collaborator
(none)
250
1
1.5
169.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Urethroplasty

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 Design

Study Type:
Observational
Actual Enrollment :
250 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Factors Predicting Urethral Stricture Recurrence After Dorsal Onlay Augmented, Buccal Mucosal Graft Urethroplasty
Actual Study Start Date :
Jul 15, 2020
Actual Primary Completion Date :
Aug 15, 2020
Actual Study Completion Date :
Aug 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Case

Patients with urethral stricture recurrence

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

Control

Patients with normal, patent urethra

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Inclusion Criteria:
  • patients who will be 2 years or more out of surgery
Exclusion Criteria:
  • patients with incomplete medical records or follow-up informations

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urology Department, Al-Azhar University Hospital Cairo Egypt 11633

Sponsors and Collaborators

  • Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abul-fotouh Ahmed, Professor of Urology and Andrology, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT04357080
Other Study ID Numbers:
  • Uro_Azhar_4_020
First Posted:
Apr 22, 2020
Last Update Posted:
Jan 13, 2021
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2021