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

NCT ID: NCT04129606

Last Updated: 2019-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-07-01

Brief Summary

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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

Detailed Description

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Conditions

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Bladder Cancer Bladder Urothelial Carcinoma Trauma Injuries Perforation of Bladder Recurrence Tumor Resection Margin Seeding, Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TURBT

Transurethral resection of bladder tumour

Group Type OTHER

Computed tomographic cystography

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CT cystography

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Refuse to complete study requirements
* muscle invasive bladder tumor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abdelwahab Hashem

OTHER

Sponsor Role lead

Responsible Party

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Abdelwahab Hashem

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nasr Eltabey, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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TURBT-BP

Identifier Type: -

Identifier Source: org_study_id

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