Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 24, 2020

Primary Completion Date

August 1, 2024

Study Completion Date

August 1, 2024

Conditions
Urinary Bladder Neoplasm
Interventions
PROCEDURE

Holmium versus Bipolar en bloc transurethral resection

"After obtaining informed consent, patients will be randomized with a 1:1 ratio using sealed envelopes that will be prepared by the department's ethical committee into 2 groups, group 1 represent the Holmium en bloc resection procedure while group 2 represents bipolar en bloc resection. Patients will be blinded to the type of intervention as well as the data collector and the statistician.~Intervention: all procedures will be done by an expert surgeon who performed over 50 cases of en bloc urinary bladder tumor resection with each energy source. In group A, Holmium en bloc resection procedure will be done under either general or spinal anesthesia, using a Holmium laser device (Cyber Ho, Quanta device, Milano, Italy). We will use a 30-40-watt power, 1-2 joules and 20-30 MHz frequency for Group A and bipolar en bloc resection for Group B. A 550 nm flexible laser fiber will be used in group A and a bipolar resection loop for group B."

Trial Locations (1)

11361

Ain Shams University Hospitals, Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER

NCT04576286 - Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder | Biotech Hunter | Biotech Hunter