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Lymph Node Dissection Before or After Cystectomy

NCT ID: NCT05939856

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-27

Study Completion Date

2024-06-23

Brief Summary

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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

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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.

Conditions

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Bladder Cancer

Keywords

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Bladder Cancer Muscle-invasive bladder cancer Radical cystectomy Lymph node dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1 Lymph node dissection before bladder resection

Lymph node dissection will be performed before bladder resection during radical cystectomy

Group Type OTHER

Lymph node dissection before bladder resection

Intervention Type OTHER

Lymph node dissection before bladder resection

2 Lymph node dissection after bladder resection

Lymph node dissection will be performed after bladder resection during radical cystectomy

Group Type OTHER

Lymph node dissection after bladder resection

Intervention Type OTHER

Lymph node dissection after bladder resection

Interventions

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Lymph node dissection before bladder resection

Lymph node dissection before bladder resection

Intervention Type OTHER

Lymph node dissection after bladder resection

Lymph node dissection after bladder resection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Anna K. Czech, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna K. Czech

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

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Department of Urology, University Hospital, Jagiellonian University

Krakow, , Poland

Site Status

Countries

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Poland

Other Identifiers

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LBOACPUJ

Identifier Type: -

Identifier Source: org_study_id