Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT

• Sponsor: Benha University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04839029
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer; Bladder Neoplasm	Procedure: Bipolar En bloc TURBT; Procedure: Monopolar En bloc TURBT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Bipolar Versus Monopolar Needlescopic En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer: A Prospective Randomized Study
• Actual Study Start Date: Nov 1, 2019
• Anticipated Primary Completion Date: Aug 30, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bipolar En bloc TURBT patient subjected to bipolar Needlescopic En bloc resection of NMIBC	Procedure: Bipolar En bloc TURBT; patients subjected to Bipolar resection of bladder tumor by Collins loop
Active Comparator: Monopolar En bloc TURBT patient subjected to Monopolar Needlescopic En bloc resection of NMIBC	Procedure: Monopolar En bloc TURBT; patients subjected to Monopolar resection of bladder tumor by Collins loop (hot Knife)

Outcome Measures

Primary Outcome Measures

1. Quality of tumor Resection [immediatly post operative]

   presence of detrusor muscle

2. adequacy of tumor Resection [2 to 6 weeks postoprative]

   Presence of residual tumor at the bed of previously resected NMIBC

Secondary Outcome Measures

1. Complications [within 30 days post-operative]

   Modified Clavien-Dindo classification scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• confirmed primary NMIBC (Ta, Tis, T1)

• Age > 18 years

Exclusion Criteria:

• MIBC

• anterior located mass ( difficult or non visualized)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banha university hospital	Banhā	Qalubia	Egypt	13511

Sponsors and Collaborators

• Benha University

Investigators

• Principal Investigator: Waleed El-Shaer, M.D, Faculty of medicine, Banha university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Waleed El-Shaer, MD, Associate professor, Benha University
• ClinicalTrials.gov Identifier: NCT04839029
• Other Study ID Numbers: IDIRB2017122601-293
• First Posted: Apr 9, 2021
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Waleed El-Shaer, MD, Associate professor, Benha University: NMIBC; TURBT; En bloc resection
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Jul 19, 2022