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

Not Applicable

• Conditions: Injuries; Resection Margin; Perforation of Bladder; Bladder Urothelial Carcinoma; Trauma; Recurrence Tumor; Seeding, Neoplasm; Bladder Cancer
• Interventions: Diagnostic Test: Computed tomographic cystography

• Registration Number: NCT04129606
• Lead Sponsor: Abdelwahab Hashem

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-15
• Last Update Submitted: 2019-10-15
• Study First Posted: 2019-10-17
• Last Update Posted: 2019-10-17
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TURBT	Computed tomographic cystography	Transurethral resection of bladder tumour

Primary Outcome Measures

Name	Time	Method
Prevalence of bladder perforation post-Transurethral resection of bladder tumour	24 months	calculate the numbers of bladder perforation diagnosed by CT cystogram divided by the total number of patients

Secondary Outcome Measures

Name	Time	Method
Correlation between the cystoscopical and radiological bladder perforation	24 months	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	24 months	calculate the number of recurrence pf bladder tumor in bladder perforation at 2 year follow up

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Aldakahlia, Egypt