Clinical trial NCT05939856: Lymph Node Dissection Before or After Cystectomy
Official title: Lymph Node Dissection Before or After Cystectomy - Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Muscle-invasive bladder cancer
Radical cystectomy
Lymph node dissection
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Early complications rate
timeFrame: Within 30 days after the surgery
Secondary outcomes:
measure: Lymph node yield
timeFrame: When pathology report is available (on average, the pathology report is available within 14 days after the surgery)
measure: Operative time
timeFrame: At the end of the surgery (after the completion of skin closure and wound dressing)
Other outcomes:
measure: Intraoperative complications rate
timeFrame: At the end of the surgery (after the completion of skin closure and wound dressing)
measure: Positive surgical margin rate
timeFrame: When pathology report is available (on average, the pathology report is available within 14 days after the surgery)
measure: Ureters clamping time
timeFrame: At the end of the surgery (after the completion of skin closure and wound dressing)
measure: Postoperative estimated glomerular filtration rate (eGFR)
timeFrame: Within 7 days after the surgery
measure: Complications severity and type
timeFrame: Within 30 days after the surgery
Locations:
city: Krakow
country: Poland
facility: Department of Urology, University Hospital, Jagiellonian University
Study officials:
affiliation: Jagiellonian University
name: Anna K. Czech
role: PRINCIPAL_INVESTIGATOR
References: