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Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT

Primary Purpose

Bladder Cancer, Bladder Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bipolar En bloc TURBT
Monopolar En bloc TURBT
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring NMIBC, TURBT, En bloc resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Banha university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bipolar En bloc TURBT

Monopolar En bloc TURBT

Arm Description

patient subjected to bipolar Needlescopic En bloc resection of NMIBC

patient subjected to Monopolar Needlescopic En bloc resection of NMIBC

Outcomes

Primary Outcome Measures

Quality of tumor Resection
presence of detrusor muscle
adequacy of tumor Resection
Presence of residual tumor at the bed of previously resected NMIBC

Secondary Outcome Measures

Complications
Modified Clavien-Dindo classification scale

Full Information

First Posted
April 7, 2021
Last Updated
July 17, 2022
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT04839029
Brief Title
Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT
Official Title
Bipolar Versus Monopolar Needlescopic En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Bladder Neoplasm
Keywords
NMIBC, TURBT, En bloc resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bipolar En bloc TURBT
Arm Type
Experimental
Arm Description
patient subjected to bipolar Needlescopic En bloc resection of NMIBC
Arm Title
Monopolar En bloc TURBT
Arm Type
Active Comparator
Arm Description
patient subjected to Monopolar Needlescopic En bloc resection of NMIBC
Intervention Type
Procedure
Intervention Name(s)
Bipolar En bloc TURBT
Intervention Description
patients subjected to Bipolar resection of bladder tumor by Collins loop
Intervention Type
Procedure
Intervention Name(s)
Monopolar En bloc TURBT
Intervention Description
patients subjected to Monopolar resection of bladder tumor by Collins loop (hot Knife)
Primary Outcome Measure Information:
Title
Quality of tumor Resection
Description
presence of detrusor muscle
Time Frame
immediatly post operative
Title
adequacy of tumor Resection
Description
Presence of residual tumor at the bed of previously resected NMIBC
Time Frame
2 to 6 weeks postoprative
Secondary Outcome Measure Information:
Title
Complications
Description
Modified Clavien-Dindo classification scale
Time Frame
within 30 days post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: confirmed primary NMIBC (Ta, Tis, T1) Age > 18 years Exclusion Criteria: MIBC anterior located mass ( difficult or non visualized)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waleed El-Shaer, M.D
Phone
01015767331
Ext
0020
Email
waleed_elshaer@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-Shaer, M.D
Organizational Affiliation
Faculty of medicine, Banha university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha university hospital
City
Banhā
State/Province
Qalubia
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT

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