Complications of Transurethral Resection of the Bladder Tumour

Bladder Cancer Clinical Trial

— ComTUR  

Official title:

Complications of Transurethral Resection of the Bladder Tumour: A Prospective Analysis of Incidence and Predictive Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029663
• Other study ID #: 12/2016
• Status: Completed
• Start date: December 2016
• Est. completion date: November 2017

Study information

• Verified date: January 2017
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective study enrolling consecutive patients who undergo transurethral resection of the bladder tumour (TURBT) aimed at determination of a safety of the procedure. Study end-points are incidence, severity and predictive factors of surgical complications. The study secondary aim is a validation of Clavien Dindo scoring system for reporting complication of TURBT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 983
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary or recurrent bladder tumour

• informed consent to undergo the surgery

Exclusion Criteria:

• age <18 years

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Transurethral resection of the bladder tumour

Locations

Country	Name	City	State
Poland	Medical University of Warsaw, Dept. of Urology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications rate		30 days postop
Secondary	Complications severity	Severity of surgical complications according to Clavien-Dindo classification	30 days postop