Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT

Not Applicable

• Conditions: Bladder Neoplasm; Bladder Cancer
• Interventions: Procedure: Bipolar En bloc TURBT; Procedure: Monopolar En bloc TURBT

• Registration Number: NCT04839029
• Lead Sponsor: Benha University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-17
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-08-30
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• confirmed primary NMIBC (Ta, Tis, T1)
• Age > 18 years

Exclusion Criteria

• MIBC
• anterior located mass ( difficult or non visualized)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar En bloc TURBT	Bipolar En bloc TURBT	patient subjected to bipolar Needlescopic En bloc resection of NMIBC
Monopolar En bloc TURBT	Monopolar En bloc TURBT	patient subjected to Monopolar Needlescopic En bloc resection of NMIBC

Primary Outcome Measures

Name	Time	Method
Quality of tumor Resection	immediatly post operative	presence of detrusor muscle
adequacy of tumor Resection	2 to 6 weeks postoprative	Presence of residual tumor at the bed of previously resected NMIBC

Secondary Outcome Measures

Name	Time	Method
Complications	within 30 days post-operative	Modified Clavien-Dindo classification scale

Trial Locations

Locations (1)

Banha university hospital; 🇪🇬 Banhā, Qalubia, Egypt