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Bladder cancer is the 4th most common cancer in men and 5th most common type of cancer in Canada. Urothelial cancer accounts for approximately 90% of malignancies. At diagnosis, over 75% of cases are classified as non-muscle invasive (NMIBC), and with appropriate treatment, the majority of these patients achieve positive outcomes. The progression rate of NMIBC to Muscle-invasive bladder cancer (MIBC) varies between 5-50% at 5 years dependent on histopathological features such as grade, stage, presence of CIS and age (Carcinoma in Situ). The optimal treatment of MIBC (T2-T4N0M0) consists of neoadjuvant cisplatin-based chemotherapy followed by Radical cystectomy and urinary diversion (RCUD). In the last couple of decades, RCUD has also gained attention for treating patients with high-risk non-muscle invasive bladder cancer. Despite advancements in surgical techniques and the rise of minimally invasive alternatives, complications after surgery remain frequent, with morbidity rates of approximately 50%.
Several uncertainties persist in surgical practice, including the role of perioperative ureteric stenting during RCUD. Perioperative ureteric stenting is intended to minimize urinary leakage from the newly created uretero-enteric anastomosis and to prevent early obstruction caused by anastomotic swelling. However, stenting may increase the risk of urinary tract infections (UTIs) and necessitate additional follow-up for stent removal. Peng et al. conducted the most recent systematic review in 2021, demonstrating that ureteral stents in RCUD were linked to higher rates of anastomotic strictures. Their review did not provide evidence that these stents were more effective than not using stents in preventing post-diversion urinary leakage. The review underscored the scarcity of prospective randomized controlled trials examining the safety and effectiveness of stenting in this context. The sole prospective (non-randomized) study assessing stent dwell / retention time after RCUD demonstrated early stent removal (2 weeks) had decreased 90-day readmissions and UTIs.
Therefore, the investigators aimed to determine the feasibility of conducting a definitive randomized trial to evaluate patients undergoing radical cystectomy and ileal conduit formation to receive either early stent removal (5-7 days) or late stent removal (4-6 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Early Stent removal |
|
| Arm B | Active Comparator | Late Stent removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Stent removal | Procedure | Ureteral JJ stents removed 5-7 days after radical cystectomy and ileal conduit formation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complication rates | within 30 days: | |
| Feasibility Outcomes |
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rates | within 90 days | |
| Readmission rates | within 90 days | |
| Complication rates |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Length of inpatient hospital stay following surgery | 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaydee Connors, BSc | Contact | 519-685-8500 | 56366 | kaydee.connors@lhsc.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria Hospital | Recruiting | London | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32303901 | Background | Beano H, He J, Hensel C, Worrilow W, Townsend W, Gaston K, Clark PE, Riggs S. Safety of decreasing ureteral stent duration following radical cystectomy. World J Urol. 2021 Feb;39(2):473-479. doi: 10.1007/s00345-020-03191-2. Epub 2020 Apr 17. | |
| 34416355 | Background | Peng YL, Ning K, Wu ZS, Li ZY, Deng MH, Xiong LB, Yu CP, Zhang ZL, Liu ZW, Lu HM, Zhou FJ. Ureteral stents cannot decrease the incidence of ureteroileal anastomotic stricture and leakage: A systematic review and meta-analysis. Int J Surg. 2021 Sep;93:106058. doi: 10.1016/j.ijsu.2021.106058. Epub 2021 Aug 18. |
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| Late Stent removal | Procedure | Ureteral JJ stents removed 4-6 weeks after radical cystectomy and ileal conduit formation |
|
The secondary outcomes will also include composite Uretero-enteric anastomosis (UEA) complications after radical cystectomy and ileal conduit formation.
| within 1 year |
| 33938798 | Background | Bhindi B, Kool R, Kulkarni GS, Siemens DR, Aprikian AG, Breau RH, Brimo F, Fairey A, French C, Hanna N, Izawa JI, Lacombe L, McPherson V, Rendon RA, Shayegan B, So AI, Zlotta AR, Black PC, Kassouf W. Canadian Urological Association guideline on the management of non-muscle-invasive bladder cancer - Full-text. Can Urol Assoc J. 2021 Aug;15(8):E424-E460. doi: 10.5489/cuaj.7367. No abstract available. |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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