Complications of Transurethral Resection of the Bladder Tumour (ComTUR)

December 27, 2018 updated by: Medical University of Warsaw

Complications of Transurethral Resection of the Bladder Tumour: A Prospective Analysis of Incidence and Predictive Factors

This is a prospective study enrolling consecutive patients who undergo transurethral resection of the bladder tumour (TURBT) aimed at determination of a safety of the procedure. Study end-points are incidence, severity and predictive factors of surgical complications. The study secondary aim is a validation of Clavien Dindo scoring system for reporting complication of TURBT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

983

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02005
        • Medical University of Warsaw, Dept. of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients undergoing TURBT

Description

Inclusion Criteria:

  • primary or recurrent bladder tumour
  • informed consent to undergo the surgery

Exclusion Criteria:

  • age <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complications rate
Time Frame: 30 days postop
30 days postop

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications severity
Time Frame: 30 days postop
Severity of surgical complications according to Clavien-Dindo classification
30 days postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 24, 2017

Study Record Updates

Last Update Posted (Actual)

December 28, 2018

Last Update Submitted That Met QC Criteria

December 27, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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