Clinical trial NCT04610385: Ileal Conduit Versus Cutaneous Ureterostomy After Radical Cystectomy
Official title: Comparative Study Between Ileal Conduit and Unilateral Cutaneous Ureterostomy With Separate Stomas Post Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Satisfaction
Bladder Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: quality of life measure
timeFrame: 1 year postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.