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NCT Number: NCT05939856

Lymph Node Dissection Before or After Cystectomy

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, University Hospital, Jagiellonian University

Krakow, 30-688, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lymph node dissection before bladder resection

Other

Lymph node dissection before bladder resection

Lymph node dissection after bladder resection

Other

Lymph node dissection after bladder resection

Primary outcomes

  1. Early complications rate

    Time frame: Within 30 days after the surgery

    Complications rate within 30 postoperative days

Secondary outcomes

  1. Lymph node yield

    Time frame: When pathology report is available (on average, the pathology report is available within 14 days after the surgery)

    Number of lymph nodes removed

  2. Operative time

    Time frame: 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 outcomes

  1. Intraoperative complications rate

    Time frame: At the end of the surgery (after the completion of skin closure and wound dressing)

    Intraoperative complications rate

  2. Positive surgical margin rate

    Time frame: When pathology report is available (on average, the pathology report is available within 14 days after the surgery)

    Positive surgical margin rate

  3. Ureters clamping time

    Time frame: At the end of the surgery (after the completion of skin closure and wound dressing)

    Ureters clamping time

  4. Postoperative estimated glomerular filtration rate (eGFR)

    Time frame: Within 7 days after the surgery

    eGFR on postoperative day 1 and day 4-7

  5. Complications severity and type

    Time frame: Within 30 days after the surgery

    Severity and type of complications

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Lymph Node Dissection Before or After Cystectomy - Pilot Randomized Controlled Trial

Acronym: LBOACP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2023
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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