Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Lymph node dissection before bladder resection | Other | Lymph node dissection will be performed before bladder resection during radical cystectomy |
|
| 2 Lymph node dissection after bladder resection | Other | Lymph node dissection will be performed after bladder resection during radical cystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymph node dissection before bladder resection | Other | Lymph node dissection before bladder resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early complications rate | Complications rate within 30 postoperative days | Within 30 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Lymph node yield | Number of lymph nodes removed | When pathology report is available (on average, the pathology report is available within 14 days after the surgery) |
| Operative time | Total operative time, bladder resection time, lymph node dissection time |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complications rate | Intraoperative complications rate | At the end of the surgery (after the completion of skin closure and wound dressing) |
| Positive surgical margin rate | Positive surgical margin rate |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anna K. Czech | Jagiellonian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, University Hospital, Jagiellonian University | Krakow | 30-688 | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lymph node dissection after bladder resection | Other | Lymph node dissection after bladder resection |
|
| At the end of the surgery (after the completion of skin closure and wound dressing) |
| When pathology report is available (on average, the pathology report is available within 14 days after the surgery) |
| Ureters clamping time | Ureters clamping time | At the end of the surgery (after the completion of skin closure and wound dressing) |
| Postoperative estimated glomerular filtration rate (eGFR) | eGFR on postoperative day 1 and day 4-7 | Within 7 days after the surgery |
| Complications severity and type | Severity and type of complications | Within 30 days after the surgery |
| 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 |