Ileal Conduit Versus Cutaneous Ureterostomy After Radical Cystectomy

NCT04610385 | Unknown

• 1 other identifier: bladder caner treatment
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patient Satisfaction; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• quality of life measure

  using FAST-BCI

  1 year postoperative

Study Arms (2)

ileal conduit

Procedure: radical cystectomy with urinary diversion

cutaneous ureterostomy

Procedure: radical cystectomy with urinary diversion

Interventions

radical cystectomy with urinary diversion PROCEDURE

surgical removal of the urinary bladder and other organs and perform a urinary shunt

cutaneous ureterostomy; ileal conduit

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients with bladder cancer eligible for surgery

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 30982146 BACKGROUND

• 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.

  PMID: 30145025 BACKGROUND

• 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.

  PMID: 24330062 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Urinary Bladder Neoplasms

Interventions

Cystectomy; Urinary Diversion

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; 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

Central Study Contacts

Mena H Mahdy, resident

CONTACT

01008413768; menaahosam1995@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: October 30, 2020
• Study Start: November 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: October 30, 2020

Record last verified: 2020-10