Bladder Perforation Post-TURBT: Definition, Incidence and Natural HistoryStudy (TURBT-BP)

October 15, 2019 updated by: Abdelwahab Hashem

Bladder Perforation Post-TURBT: Definition, Incidence and Natural History. A Prospective Cohort Study

In view of sparse data of precise definition, risk factors, natural history and management of bladder perforation following Transurethral resection of bladder tumour (TURBT). We aim to correlate the relation between the site, depth and extent of resection with bladder perforation. Also, correlation between vertical depth, horizontal extent of resection and recurrence and progression of tumor

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

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

    • Aldakahlia
      • Mansoura, Aldakahlia, Egypt, 35516
        • Urology and nephrology center

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

Description

Inclusion Criteria:

  • papillary bladder tumor (denovo or recurrent)
  • resectable nodular bladder tumor

Exclusion Criteria:

  • Refuse to complete study requirements
  • muscle invasive bladder tumor

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TURBT
Transurethral resection of bladder tumour
CT cystogram performed after the procedure by the injection of 400mL of 1/4 saline-diluted contrast solution (meglumine ioxitalamate) with low-pressure infusion (60 cm gravity pressure) through the Foley catheter.
Other Names:
  • CT cystography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of bladder perforation post-Transurethral resection of bladder tumour
Time Frame: 24 months
calculate the numbers of bladder perforation diagnosed by CT cystogram divided by the total number of patients
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the cystoscopical and radiological bladder perforation
Time Frame: 24 months
compare the numbers of bladder perforation diagnosed by CT cystogram by the number of bladder perforation described by surgeon
24 months
assess the recurrence free rate in bladder perforation groups at 2 year follow up
Time Frame: 24 months
calculate the number of recurrence pf bladder tumor in bladder perforation at 2 year follow up
24 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Nasr Eltabey, MD, Mansoura University

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 (Actual)

July 1, 2019

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

October 15, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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