Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT

July 17, 2022 updated by: Waleed El-Shaer, MD, Benha University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Qalubia
      • Banhā, Qalubia, Egypt, 13511
        • Recruiting
        • Banha University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of tumor Resection
Time Frame: immediatly post operative
presence of detrusor muscle
immediatly post operative
adequacy of tumor Resection
Time Frame: 2 to 6 weeks postoprative
Presence of residual tumor at the bed of previously resected NMIBC
2 to 6 weeks postoprative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: within 30 days post-operative
Modified Clavien-Dindo classification scale
within 30 days post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 17, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDIRB2017122601-293

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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