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Trial Title:
Lymph Node Dissection Before Or After Cystectomy
NCT ID:
NCT05939856
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Bladder Cancer
Muscle-invasive bladder cancer
Radical cystectomy
Lymph node dissection
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Lymph node dissection before bladder resection
Description:
Lymph node dissection before bladder resection
Arm group label:
1 Lymph node dissection before bladder resection
Intervention type:
Other
Intervention name:
Lymph node dissection after bladder resection
Description:
Lymph node dissection after bladder resection
Arm group label:
2 Lymph node dissection after bladder resection
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Urology, University Hospital, Jagiellonian University
Address:
City:
Krakow
Zip:
30-688
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Anna K Czech, M.D.
Phone:
0048124002500
Email:
aka.czech@uj.edu.pl
Contact backup:
Last name:
Katarzyna Gronostaj, Ph.D.
Phone:
0048124002500
Email:
katarzyna.gronostaj@uj.edu.pl
Start date:
July 28, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Jagiellonian University
Agency class:
Other
Source:
Jagiellonian University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05939856
