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

NCT04406168 | Unknown DMC FDA Drug

• 1 other identifier: urinary diversions outcomes
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

urinary diversion PROCEDURE

follow up outcomes of urinary diversion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \* All patients underwent radical cystectomy more than 1 year

You may not qualify if:

• incomplete data
• patients underwent RC outside urology department and presented for treatment of complications.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Elgam3a, 11174, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Urinary Diversion

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• salah s abdelhafez

  prof

  STUDY DIRECTOR

Central Study Contacts

islam m abdellah

CONTACT

+201090088672; islam01183@med.au.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of urology

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 28, 2020
• Study Start: June 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

EG (1)