Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595446
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
A Feasibility Randomized Trial Evaluating Early Vs Late Stent Removal Following Radical Cystectomy and Ileal Conduit Formation for Bladder Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Feasibility Randomized Controlled Trial Evaluating Early Vs Late Stent Removal Following Radical Cystectomy and Ileal Conduit Formation for Bladder Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STENT-OPT
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None