Ileal Conduit Versus Cutaneous Ureterostomy After Radical Cystectomy

Comparative Study Between Ileal Conduit and Unilateral Cutaneous Ureterostomy With Separate Stomas Post Radical Cystectomy

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer; Patient Satisfaction
• Intervention / Treatment: Procedure: radical cystectomy with urinary diversion

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

Contacts and Locations

• Study Contact: Name: Mena H Mahdy, resident; Phone Number: 01008413768; Email: menaahosam1995@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with bladder cancer eligible for radical cystectomy and will undergo either ileal conduit or unilateral cutaneous ureterostomy with separate stomas with age range from 45 to 85 years regardless of gender.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ileal conduit	Procedure: radical cystectomy with urinary diversion; surgical removal of the urinary bladder and other organs and perform a urinary shunt
cutaneous ureterostomy	Procedure: radical cystectomy with urinary diversion; surgical removal of the urinary bladder and other organs and perform a urinary shunt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life measure	using FAST-BCI	1 year postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Tsaturyan A, Sahakyan S, Muradyan A, Fanarjyan S, Tsaturyan A. A new modification of tubeless cutaneous ureterostomy following radical cystectomy. Int Urol Nephrol. 2019 Jun;51(6):959-967. doi: 10.1007/s11255-019-02145-x. Epub 2019 Apr 13.
• Moeen AM, Safwat AS, Gadelmoula MM, Moeen SM, Abonnoor AEI, Abbas WM, ElGanainy EO, El-Taher AM. Health related quality of life after urinary diversion. Which technique is better? J Egypt Natl Canc Inst. 2018 Sep;30(3):93-97. doi: 10.1016/j.jnci.2018.08.001. Epub 2018 Aug 23.
• Lee RK, Abol-Enein H, Artibani W, Bochner B, Dalbagni G, Daneshmand S, Fradet Y, Hautmann RE, Lee CT, Lerner SP, Pycha A, Sievert KD, Stenzl A, Thalmann G, Shariat SF. Urinary diversion after radical cystectomy for bladder cancer: options, patient selection, and outcomes. BJU Int. 2014 Jan;113(1):11-23. doi: 10.1111/bju.12121.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 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: bladder caner treatment

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: No
• Studies a U.S. FDA-regulated device product: No