NCT05939856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

July 27, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2024

Completed
Last Updated

December 10, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

June 6, 2023

Last Update Submit

December 5, 2024

Conditions

Bladder Cancer

Keywords

Bladder CancerMuscle-invasive bladder cancerRadical cystectomyLymph node dissection

Outcome Measures

Primary Outcomes (1)

  • Early complications rate

    Complications rate within 30 postoperative days

    Within 30 days after the surgery

Secondary Outcomes (2)

  • Lymph node yield

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

  • Operative time

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

Other Outcomes (5)

  • Intraoperative complications rate

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

  • Positive surgical margin rate

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

  • Ureters clamping time

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

  • +2 more other outcomes

Study Arms (2)

1 Lymph node dissection before bladder resection

OTHER

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

Other: Lymph node dissection before bladder resection

2 Lymph node dissection after bladder resection

OTHER

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

Other: Lymph node dissection after bladder resection

Interventions

Lymph node dissection before bladder resectionOTHER

Lymph node dissection before bladder resection

1 Lymph node dissection before bladder resection
Lymph node dissection after bladder resectionOTHER

Lymph node dissection after bladder resection

2 Lymph node dissection after bladder resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing radical cystectomy for bladder cancer in the Department of Urology University Hospital in Krakow

You may not qualify if:

  • Previous pelvic lymph node dissection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, University Hospital, Jagiellonian University

Krakow, 30-688, Poland

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Anna K. Czech

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2023

First Posted

July 11, 2023

Study Start

July 27, 2023

Primary Completion

June 23, 2024

Study Completion

June 23, 2024

Last Updated

December 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)