- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04129606
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
Status
Unknown
Conditions
Intervention / Treatment
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:
|
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- TURBT-BP
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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