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NCT04129606 Clinical Trial

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

Bladder Cancer Clinical Trial

— TURBT-BP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04129606
Other study ID # TURBT-BP
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date July 1, 2021

Study information
Verified date October 2019
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- papillary bladder tumor (denovo or recurrent)

- resectable nodular bladder tumor

Exclusion Criteria:

- Refuse to complete study requirements

- muscle invasive bladder tumor

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Computed tomographic cystography
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.

Locations
Country Name City State
Egypt Urology and Nephrology Center Mansoura Aldakahlia

Sponsors (1)
Lead Sponsor Collaborator
Abdelwahab Hashem

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of bladder perforation post-Transurethral resection of bladder tumour calculate the numbers of bladder perforation diagnosed by CT cystogram divided by the total number of patients 24 months
Secondary Correlation between the cystoscopical and radiological bladder perforation compare the numbers of bladder perforation diagnosed by CT cystogram by the number of bladder perforation described by surgeon 24 months
Secondary assess the recurrence free rate in bladder perforation groups at 2 year follow up calculate the number of recurrence pf bladder tumor in bladder perforation at 2 year follow up 24 months
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