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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: urinary diversion

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: islam m abdellah; Phone Number: +201090088672; Email: islam01183@med.au.edu.eg

Study Locations

• Egypt
  • Elgam3a
    • Assiut, Elgam3a, Egypt, 11174
      • Recruiting
      • Assiut University
      • Contact: tarek m elgamaal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All cases that fulfil the selection criteria that have been admitted in Asyut university urology hospital (non probability sample size) with expected size of 40 patients starting from 01/01/2013 to1/05/2020.

Additionally, the competence of follow-up will be approved by imaging and medical records.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of patients developed recurrence	recurrence of cancer	1 year post operative
Survival rate (overall survival & cancer specific)	patient live post operative	1 year post operative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: salah s abdelhafez, Prof

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: May 10, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: urinary diversions outcomes

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No