Laser vs. Electorsurgical Enbloc Resection of Bladder Tumours
Laser Versus Electrical Transurethral Enbloc Resection of Non-muscle Invasive Bladder Tumours: A Randomized Trial
1 other identifier
interventional
100
1 country
1
Brief Summary
To compare use of electrosurgical energy in doing En Bloc resection of bladder tumours against Laser Energy for En Bloc resection of bladder tumours Patients with non muscle invasive bladder cancer will be enrolled and randomized into either of the two techniques
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 17, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJuly 26, 2019
July 1, 2019
2 years
July 17, 2019
July 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
number of failed En Bloc resection procedures (need for conversion to conventional resection)
to assess the need of conversion to conventional Transurethral resection of bladder tumor
intraoperative
Secondary Outcomes (2)
number of cases with esidual tumours
4 weeks postoperative
recurrence rate
1 year post operative
Study Arms (2)
laser ERBT
ACTIVE COMPARATORLaser En Bloc Resection Of bladder Tumor
electro-surgical ERBT
ACTIVE COMPARATORelectro-surgical En Bloc Resection Of bladder Tumor
Interventions
Using laser beam starting the procedure with circumferential incision few millimetres around the tumour then lifting the tumour and dissection underneath its muscle base
Using electro-surgical loop starting the procedure with circumferential incision few millimetres around the tumour then lifting the tumour and dissection underneath its muscle base
Eligibility Criteria
You may not qualify if:
- Tumor criteria
- MIBC
- Tumours deemed not legible for Enbloc resection as Judged by the surgeon e.g.
- location: Tumour in diverticulum, at the anterior wall or close to ureteric orifice….etc
- Wide base tumour
- Patients criteria
- Bleeding tendency
- Synchronous either urethral tumours or upper urinary tract tumours
- History of CIS
- Contracted bladder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology and Nprhology Center
Al Mansurah, Aldakahlia, 35516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Elshal, MD
Mansoura University
Central Study Contacts
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
- Clinical Professor
Study Record Dates
First Submitted
July 17, 2019
First Posted
July 23, 2019
Study Start
July 1, 2019
Primary Completion
July 1, 2021
Study Completion
June 30, 2022
Last Updated
July 26, 2019
Record last verified: 2019-07