NCT04839029

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

2.8 years

First QC Date

April 7, 2021

Last Update Submit

July 17, 2022

Conditions

Bladder CancerBladder Neoplasm

Keywords

NMIBCTURBTEn bloc resection

Outcome Measures

Primary Outcomes (2)

  • Quality of tumor Resection

    presence of detrusor muscle

    immediatly post operative

  • adequacy of tumor Resection

    Presence of residual tumor at the bed of previously resected NMIBC

    2 to 6 weeks postoprative

Secondary Outcomes (1)

  • Complications

    within 30 days post-operative

Study Arms (2)

Bipolar En bloc TURBT

EXPERIMENTAL

patient subjected to bipolar Needlescopic En bloc resection of NMIBC

Procedure: Bipolar En bloc TURBT

Monopolar En bloc TURBT

ACTIVE COMPARATOR

patient subjected to Monopolar Needlescopic En bloc resection of NMIBC

Procedure: Monopolar En bloc TURBT

Interventions

Bipolar En bloc TURBTPROCEDURE

patients subjected to Bipolar resection of bladder tumor by Collins loop

Bipolar En bloc TURBT
Monopolar En bloc TURBTPROCEDURE

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

Monopolar En bloc TURBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha university hospital

Banhā, Qalyubia Governorate, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Waleed El-Shaer, M.D

    Faculty of medicine, Banha university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Waleed El-Shaer, M.D

CONTACT

01015767331waleed_elshaer@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 9, 2021

Study Start

November 1, 2019

Primary Completion

August 30, 2022

Study Completion

September 1, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

EG(1)