Ileal Conduit Versus Cutaneous Ureterostomy After Radical Cystectomy
NCT ID: NCT04610385
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2020-11-01
2022-10-30
Brief Summary
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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
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ileal conduit
radical cystectomy with urinary diversion
surgical removal of the urinary bladder and other organs and perform a urinary shunt
cutaneous ureterostomy
radical cystectomy with urinary diversion
surgical removal of the urinary bladder and other organs and perform a urinary shunt
Interventions
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radical cystectomy with urinary diversion
surgical removal of the urinary bladder and other organs and perform a urinary shunt
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients who are unfit for surgery.
* patients refusing cystectomy.
* patients with metastatic or inoperable cancer bladder
45 Years
85 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mena Hosam Mahdy
resident of urology
Central Contacts
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References
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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.
Other Identifiers
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bladder caner treatment
Identifier Type: -
Identifier Source: org_study_id