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

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

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

Official Title
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Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder: A Randomized Controlled Trial

Conditions
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Urinary Bladder Neoplasm

Intervention / Treatment
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* Procedure: Holmium versus Bipolar en bloc transurethral resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Holmium en bloc resection<br>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 | Procedure: Holmium versus Bipolar en bloc transurethral resection<br>* 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.<br>|
| Active Comparator: bipolar en bloc resection<br>bipolar en bloc tumor resection of urinary bladder tumors | Procedure: Holmium versus Bipolar en bloc transurethral resection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participant with Conversion to the TURBT | conversion from the enbloc way of resection to the standard trans-urethral resection of bladder tumors | intraoperative finding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | calculation of operative time in minutes | intraoperative finding | 
| Presence of detrusor muscle in resected sample | presence of muscle layer in the pathological specimen (Yes/No) | one day after surgery during pathological evaluation | 
| Resected specimen's edge | tumor free margin (Yes/No) | one day after surgery during pathological evaluation | 
| intraoperative complication: bladder perforation | (Yes/No) bladder perforation | intraoperative | 
| Incidence of obturator reflex | (Yes/No) energy induced obturator reflex | intraoperative | 
| hematuria | (Yes/No) | postoperative complication up to 2 weeks | 
| Post-operative catheterization time in hours | time till catheter removal in days | postoperative complication up to 2 weeks | 
| Postoperative irrigation time in hours | hours for the need of postoperative irrigation | postoperative in hours maximum 1 day | 
| Recurrence rate of tumors according to time interval | recurrence of tumor in the follow up cystoscopy | 1 year | 
| Recurrence rate of tumors according to tumor location | recurrence of tumor in the follow up cystoscopy in the same site or in different site | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary bladder tumors, en bloc resection, holmium laser, bipolar, TURBT