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NCT04406168 Clinical Trial

Assessment of Urinary Diversions Outcomes Post Radical Cystectomy in Asyut University Urology Hospital

Bladder Cancer Clinical Trial

Official title:
Assessment of Urinary Diversions Outcomes Post Radical Cystectomy in Asyut University Urology Hospital

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04406168
Other study ID # urinary diversions outcomes
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date May 1, 2023

Study information
Verified date May 2020
Source Assiut University
Contact islam m abdellah
Phone +201090088672
Email islam01183@med.au.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Radical cystectomy (RC) for bladder cancer requires reconstruction of the lower urinary tract. Both continent and incontinent diversions are available for urinary reconstruction after RC. Types of urinary diversions include ( ileal conduit, uretero-cutaneous, ureterosigmoidostomy and orthotopic bladder) The decision process is complex and involves consideration of issues related to cancer stage, patient comorbidities, treatment needs, and patient desires related to Quality of life and intraoperative findings. Outcomes of urinary diversions include 1- survival rate (cancer specific or overall survival). 2- Oncological failure (local, distant or LNs). 3- Complications (perioperative, intraoperative or post-operative).

In this study, all these outcomes will be analyzed.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date May 1, 2023
Est. primary completion date May 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- * All patients underwent radical cystectomy more than 1 year

Exclusion Criteria:

- incomplete data

- patients underwent RC outside urology department and presented for treatment of complications.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• urinary diversion
follow up outcomes of urinary diversion

Locations
Country Name City State
Egypt Assiut University Assiut Elgam3a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of patients presented by complications such as (change from baseline of the SCR - urinary tract infections - stone formation - stricture at site of anastomosis or stromal stenosis ) 1 year post operative
Primary Rate of patients developed recurrence recurrence of cancer 1 year post operative
Primary Survival rate (overall survival & cancer specific) patient live post operative 1 year post operative
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