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

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-24

Study Completion Date

2024-08-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Urinary Bladder Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Patients will be blinded to the type of intervention as well as the data collector and the statistician.

Study Groups

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Holmium en bloc resection

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

Group Type EXPERIMENTAL

Holmium versus Bipolar en bloc transurethral resection

Intervention Type PROCEDURE

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.

bipolar en bloc resection

bipolar en bloc tumor resection of urinary bladder tumors

Group Type ACTIVE_COMPARATOR

Holmium versus Bipolar en bloc transurethral resection

Intervention Type PROCEDURE

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.

Interventions

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