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

Primary Purpose

Bladder Cancer, Bladder Urothelial Carcinoma, Trauma

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Computed tomographic cystography
Sponsored by
Abdelwahab Hashem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring Perforation of Bladder, Bladder Cancer, Resection Margin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Refuse to complete study requirements
  • muscle invasive bladder tumor

Sites / Locations

  • Urology and Nephrology Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TURBT

Arm Description

Transurethral resection of bladder tumour

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
October 15, 2019
Last Updated
October 15, 2019
Sponsor
Abdelwahab Hashem
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1. Study Identification

Unique Protocol Identification Number
NCT04129606
Brief Title
Bladder Perforation Post-TURBT: Definition, Incidence and Natural HistoryStudy
Acronym
TURBT-BP
Official Title
Bladder Perforation Post-TURBT: Definition, Incidence and Natural History. A Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abdelwahab Hashem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Bladder Urothelial Carcinoma, Trauma, Injuries, Perforation of Bladder, Recurrence Tumor, Resection Margin, Seeding, Neoplasm
Keywords
Perforation of Bladder, Bladder Cancer, Resection Margin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TURBT
Arm Type
Other
Arm Description
Transurethral resection of bladder tumour
Intervention Type
Diagnostic Test
Intervention Name(s)
Computed tomographic cystography
Other Intervention Name(s)
CT cystography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of bladder perforation post-Transurethral resection of bladder tumour
Description
calculate the numbers of bladder perforation diagnosed by CT cystogram divided by the total number of patients
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Correlation between the cystoscopical and radiological bladder perforation
Description
compare the numbers of bladder perforation diagnosed by CT cystogram by the number of bladder perforation described by surgeon
Time Frame
24 months
Title
assess the recurrence free rate in bladder perforation groups at 2 year follow up
Description
calculate the number of recurrence pf bladder tumor in bladder perforation at 2 year follow up
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: papillary bladder tumor (denovo or recurrent) resectable nodular bladder tumor Exclusion Criteria: Refuse to complete study requirements muscle invasive bladder tumor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasr Eltabey, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

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

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