Bladder Cancer Requiring Cystectomy, Ureteral Stents
Conditions
Keywords
bladder cancer, cystectomy, ureteral stents
Brief summary
Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. RC complications commonly include urinary tract infections (UTIs), pyelonephritis, ureteroileal leakage and stenosis, and can occur with either ileal conduit or orthotopic neobladder diversions. Traditionally, ureteral stents are thought to support anastomotic healing and reduce the risk of anastomotic leakage and strictures; however, emerging evidence from retrospective studies suggests that stent use may paradoxically increase rates of postoperative morbidity. This randomized, multicenter and prospective study aims to compare 30-day postoperative complication rates between stented and non-stented urinary diversions in patients undergoing RC for MIBC, in both ileal conduit or neobladder with either robotic or open approaches.
Detailed description
Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. RC complications commonly include urinary tract infections (UTIs), pyelonephritis, ureteroileal leakage and stenosis, and can occur with either ileal conduit or orthotopic neobladder diversions. Traditionally, ureteral stents are thought to support anastomotic healing and reduce the risk of anastomotic leakage and strictures; however, emerging evidence from retrospective studies suggests that stent use may paradoxically increase rates of postoperative morbidity. This randomized, multicenter and prospective study aims to compare 30-day postoperative complication rates between stented and non-stented urinary diversions in patients undergoing RC for MIBC, in both ileal conduit or neobladder with either robotic or open approaches. Randomization between ureteroenteric anastomosis with or without ureteral stent placement will occur at time of surgery; the surgeon will know this information at time of surgery and the patient will be aware of the placement of stents following surgery as these are externalized and visible. The primary outcome will be complication rate in 30 days after the surgery. Secondary outcomes of this trial will include: length of stay, procedure duration, emergency room visits, patient reported pain, anastomotic leakage rate, ureteral stricture rate, post-operative nephrostomy tube placement, differences in complication rates between interrupted and running suture technique. The study will be conducted across three academic institutions: Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH) and Instituto do Câncer do Estado de São Paulo (ICESP), Brazil.
Interventions
DEVICEureteral stents
standard of care single-J externalized ureteral stents to be placed at time of radical cystectomy
DEVICEno ureteral stent
no ureteral stents used at time of radical cystectomy
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (\> 18 years old) * Muscle invasive bladder cancer or non-muscle invasive bladder cancer with indication of Radical Cystectomy * No concomitant surgeries like nephrectomies, colectomies or removal of other organs affected by the tumor (Except standard lymph node dissections as well as in men the prostate and seminal vesicles and in women the uterus, fallopian tubes, ovaries and vagina, that are considered part of the oncological radical cystectomy.) * Patients who have the capacity to understand the study procedures and provide written informed consent
Exclusion criteria
* Simultaneous surgical procedures (except those specified in the inclusion criteria that are considered part of a routine radical cystectomy) * History of prior urinary diversion * Patients who decline to participate, lack understanding of the study's purpose, or are unable to provide informed consent * Cystectomy for other reasons than Bladder cancer * Previous radiation therapy in the pelvis for any reason * Extremely debilitated patients, malnourished individuals, or those undergoing palliative or hygienic cystectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative readmission rate | 30-days after surgery | percent of patients re-admitted |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of stay | 30 days | index hospitalization (days after surgery until discharge, excluding pre-admission if applicable) |
| procedure duration | 30 days | surgical time measured from incision to closing |
| blood transfusion rate | 30 days | percent of patients requiring blood transfusion |
| Emergency room visits | 30 days | percent of patients presenting to emergency room at least once after surgery |
| patient reported pain on analog scale | 30 days | analog 0 to 10 scale where 0 is no pain (best) and 10 is excruciating pain (worst) |
| ureteral stricture rate | 30 days | percent of patients developing ureteral stricture requiring intervention (e.g. nephrostomy tube placement) |
| urine leak rate | 30 days | percent of patients developing urine leak requiring intervention (e.g. interventional radiology procedure) |
| pyelonephritis rate | 30 days | percent of patients developing of urinary tract infection (defined by clinical sequelae of infection in setting of positive urinalysis requiring treatment with antibiotics) |
Countries
Brazil, United States
Contacts
PRINCIPAL_INVESTIGATORTimothy N Clinton, MD
Brigham and Women's Hospital
Outcome results
None listed