Bladder Cancer
Conditions
Keywords
Bladder Cancer, Muscle-invasive bladder cancer, Radical cystectomy, Lymph node dissection
Brief summary
The purpose of this study is to compare different ways of performing surgery for bladder cancer. Specifically, the goal is to determine whether it is better to remove the lymph nodes before removing the bladder or after removing the bladder during radical cystectomy. The study aims to answer two main questions: * Does the order of surgical steps during radical cystectomy affect the occurrence of complications after surgery? * Does the order of surgical steps during radical cystectomy impact the duration of the operation and the number of lymph nodes removed? Participants in the study will be randomly assigned to one of two groups. One group will undergo lymph node removal before bladder resection, while the other group will have lymph node removal after bladder resection during radical cystectomy. Throughout their hospital stay and for 30 days following the operation, participants will be closely monitored for various factors including operative details, pathology results, and any complications that may arise.
Detailed description
Lymph node dissection (LND) is an integral part of radical cystectomy (RC) for bladder cancer. LND provides important diagnostic and prognostic information, and according to most studies, is associated with therapeutic benefit. The optimal extent and template for LND in bladder cancer remains to be established. Currently, there are no specific recommendations regarding the sequence of lymph nodes removal and bladder resection during radical cystectomy, and the decision is based mainly on individual surgeon preference. The aim of the LBOAC pilot randomized trial is to evaluate the difference in intraoperative parameters and postoperative outcomes between patients undergoing LND before bladder resection during RC and those undergoing LND after bladder resection during RC. LBOAC is a pilot randomized controlled trial with two parallel groups. The primary objective of the trial is the comparison of complication rate within 30 postoperative days. Secondary objectives of LBOAC include comparing lymph node yield and operative time between the two groups. Data for will be collected using electronic case report forms (eCRFs) at baseline and within 30 days after the surgery. This pilot study is designed to test feasibility of, to support the refinements of the protocol and to aid in sample calculation that can be used for larger scale trial.
Interventions
OTHERLymph node dissection before bladder resection
Lymph node dissection before bladder resection
OTHERLymph node dissection after bladder resection
Lymph node dissection after bladder resection
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing radical cystectomy for bladder cancer in the Department of Urology University Hospital in Krakow
Exclusion criteria
* Previous pelvic lymph node dissection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early complications rate | Within 30 days after the surgery | Complications rate within 30 postoperative days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymph node yield | When pathology report is available (on average, the pathology report is available within 14 days after the surgery) | Number of lymph nodes removed |
| Operative time | At the end of the surgery (after the completion of skin closure and wound dressing) | Total operative time, bladder resection time, lymph node dissection time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative estimated glomerular filtration rate (eGFR) | Within 7 days after the surgery | eGFR on postoperative day 1 and day 4-7 |
| Intraoperative complications rate | At the end of the surgery (after the completion of skin closure and wound dressing) | Intraoperative complications rate |
| Complications severity and type | Within 30 days after the surgery | Severity and type of complications |
| Positive surgical margin rate | When pathology report is available (on average, the pathology report is available within 14 days after the surgery) | Positive surgical margin rate |
| Ureters clamping time | At the end of the surgery (after the completion of skin closure and wound dressing) | Ureters clamping time |
Countries
Poland
Outcome results
None listed