Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT

NCT ID: NCT04839029

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-09-01

Brief Summary

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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

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Conditions

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Bladder Cancer Bladder Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bipolar En bloc TURBT

patient subjected to bipolar Needlescopic En bloc resection of NMIBC

Group Type EXPERIMENTAL

Bipolar En bloc TURBT

Intervention Type PROCEDURE

patients subjected to Bipolar resection of bladder tumor by Collins loop

Monopolar En bloc TURBT

patient subjected to Monopolar Needlescopic En bloc resection of NMIBC

Group Type ACTIVE_COMPARATOR

Monopolar En bloc TURBT

Intervention Type PROCEDURE

patients subjected to Monopolar resection of bladder tumor by Collins loop (hot Knife)

Interventions

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Bipolar En bloc TURBT

patients subjected to Bipolar resection of bladder tumor by Collins loop

Intervention Type PROCEDURE

Monopolar En bloc TURBT

patients subjected to Monopolar resection of bladder tumor by Collins loop (hot Knife)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* MIBC
* anterior located mass ( difficult or non visualized)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Waleed El-Shaer, MD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed El-Shaer, M.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine, Banha university

Locations

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Banha university hospital

Banhā, Qalyubia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Waleed El-Shaer, M.D

Role: CONTACT

01015767331 ext. 0020

Other Identifiers

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IDIRB2017122601-293

Identifier Type: -

Identifier Source: org_study_id

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