Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT

Bladder Cancer Clinical Trial

Official title:

Bipolar Versus Monopolar Needlescopic En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer: A Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04839029
• Other study ID #: IDIRB2017122601-293
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2022
• Source: Benha University
• Contact: Waleed El-Shaer, M.D
• Phone: 01015767331
• Email: waleed_elshaer[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-muscle invasive bladder cancers (NMIBC) compose about 80% of bladder tumors. the stranded treatment of these tumors is TURBT.

en bloc resection of NMIBC yields better mascularis propria with better oncological outcomes

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• confirmed primary NMIBC (Ta, Tis, T1)

• Age > 18 years

Exclusion Criteria:

• MIBC

• anterior located mass ( difficult or non visualized)

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Neoplasm
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Bipolar En bloc TURBT
patients subjected to Bipolar resection of bladder tumor by Collins loop
• Monopolar En bloc TURBT
patients subjected to Monopolar resection of bladder tumor by Collins loop (hot Knife)

Locations

Country	Name	City	State
Egypt	Banha university hospital	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of tumor Resection	presence of detrusor muscle	immediatly post operative
Primary	adequacy of tumor Resection	Presence of residual tumor at the bed of previously resected NMIBC	2 to 6 weeks postoprative
Secondary	Complications	Modified Clavien-Dindo classification scale	within 30 days post-operative