Ileal Conduit Versus Cutaneous Ureterostomy After Radical Cystectomy

• Conditions: Bladder Cancer; Patient Satisfaction
• Interventions: Procedure: radical cystectomy with urinary diversion

• Registration Number: NCT04610385
• Lead Sponsor: Assiut University

Brief Summary

Bladder cancer is the most common malignancy of the urinary tract and accounts for about 3.2% of all cancer worldwide where it remains the seventh most commonly diagnosed malignancy in the male population. Causative risk factors can be broadly divided into inherited and acquired due to environmental exposure ,Tobacco smoking is the most important environmental risk factor for bladder cancer(1).

Histologically, over 90% of bladder tumors are transitional cell carcinomas. The other subtypes, such as squamous cell and adenocarcinoma, are uncommon and account for 5 and \<2%, respectively(2).

Radical cystectomy with pelvic lymph node dissection with appropriate urinary diversion remains the mainstay of surgical treatment for muscle invasive bladder cancer and for high risk non muscle invasive disease. Select group of patients or those unfit or unwilling for surgery are managed by trimodal therapy utilizing transurethral resection and chemoradiotherapy.(3) The ideal urinary diversion should successfully preserve renal function while managing urinary outflow and minimizing morbidity to the patient(4).Several types of urinary diversion are present, continent and incontinent. Our study will focus on ileal conduit and cutaneous ureterostomy.

Although ileal conduit considered the standard method for incontinent urinary diversion, it is associated with early bowel related complications, i.e., bowel obstruction, prolonged ileus, and anastomotic leak which are mainly associated with bowel resection and anastomosis and late complications comprise ureteroenteric stricture, urinary fistula and stomal site complications in 25-60% of patients, including stomal stenosis, retraction, prolapsed, and parastomal herniation. Cutaneous ureterostomy may represent a method of choice for elderly and otherwise morbid patients due to its relative short duration and less bowel and metabolic complications but it has a high rate of stomal stenosis making perminant stenting is mandatory(5).

Cutaneous ureterostomy with separate stomas offers easy exchange of stents not need tertiary center with fluoroscopy or endescopy guidance compared to cutaneous ureterostomy with single stoma and this is preferable in our community.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-28
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-26
• Last Update Submitted: 2020-10-26
• Study First Posted: 2020-10-30
• Last Update Posted: 2020-10-30
• Study Start: 2020-11-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patients with bladder cancer eligible for surgery

Exclusion Criteria

• Patients who refuse to contribute in this study.
• patients who are unfit for surgery.
• patients refusing cystectomy.
• patients with metastatic or inoperable cancer bladder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ileal conduit	radical cystectomy with urinary diversion	-
cutaneous ureterostomy	radical cystectomy with urinary diversion	-

Primary Outcome Measures

Name	Time	Method
quality of life measure	1 year postoperative	using FAST-BCI