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

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Urinary Bladder Neoplasm

Treatments: Procedure: Holmium versus Bipolar en bloc transurethral resection

Study type: Interventional

Funder types: Other

Identifiers

NCT04576286

FMASU R32/2020

Details and patient eligibility

About

En bloc resection of bladder tumors (ERBT) may improve staging quality and perioperative morbidity and influence tumour recurrence

Full description

Modern laser technology has led to new alternatives to conventional TURBT (cTURBT). The advocates of ERBT have three goals: to improve resection quality, lower perioperative complication rates, and decrease recurrence rates at resection sites. The present study is the first to compare the results of laser and electric en bloc resection of bladder cancer with respect to the aforementioned goals.

the investigators aim to compare the clinical outcome in the form of safety and efficacy between Holmium and bipolar transurethral en bloc resection of urinary bladder tumors.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients of both sexes presented with urinary bladder tumor aiming for complete resection as diagnosed by Ultrasound with or without CT prior histopathological assessment.

Exclusion criteria

• Patients with signs of extravesical tumor extension where complete resection will not beneficial or unable to proceed to complete resection due to huge tumor burden either huge single tumor more than 5 cm or multiple tumors that are not candidate for complete resection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Holmium en bloc resection

Experimental group

Description:

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

Treatment:

Procedure: Holmium versus Bipolar en bloc transurethral resection

bipolar en bloc resection

Active Comparator group

Description:

bipolar en bloc tumor resection of urinary bladder tumors

Treatment:

Procedure: Holmium versus Bipolar en bloc transurethral resection