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

Primary Purpose

Urinary Bladder Neoplasm

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Holmium versus Bipolar en bloc transurethral resection
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasm focused on measuring urinary bladder tumors, en bloc resection, holmium laser, bipolar, TURBT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ain Shams University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Holmium en bloc resection

bipolar en bloc resection

Arm 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

bipolar en bloc tumor resection of urinary bladder tumors

Outcomes

Primary Outcome Measures

number of participant with Conversion to the TURBT
conversion from the enbloc way of resection to the standard trans-urethral resection of bladder tumors

Secondary Outcome Measures

Operative time
calculation of operative time in minutes
Presence of detrusor muscle in resected sample
presence of muscle layer in the pathological specimen (Yes/No)
Resected specimen's edge
tumor free margin (Yes/No)
intraoperative complication: bladder perforation
(Yes/No) bladder perforation
Incidence of obturator reflex
(Yes/No) energy induced obturator reflex
hematuria
(Yes/No)
Post-operative catheterization time in hours
time till catheter removal in days
Postoperative irrigation time in hours
hours for the need of postoperative irrigation
Recurrence rate of tumors according to time interval
recurrence of tumor in the follow up cystoscopy
Recurrence rate of tumors according to tumor location
recurrence of tumor in the follow up cystoscopy in the same site or in different site

Full Information

First Posted
September 16, 2020
Last Updated
October 1, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04576286
Brief Title
Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder
Official Title
Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 24, 2020 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasm
Keywords
urinary bladder tumors, en bloc resection, holmium laser, bipolar, TURBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
Patients will be blinded to the type of intervention as well as the data collector and the statistician.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Holmium en bloc resection
Arm Type
Experimental
Arm 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
Arm Title
bipolar en bloc resection
Arm Type
Active Comparator
Arm Description
bipolar en bloc tumor resection of urinary bladder tumors
Intervention Type
Procedure
Intervention Name(s)
Holmium versus Bipolar en bloc transurethral resection
Intervention 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. 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.
Primary Outcome Measure Information:
Title
number of participant with Conversion to the TURBT
Description
conversion from the enbloc way of resection to the standard trans-urethral resection of bladder tumors
Time Frame
intraoperative finding
Secondary Outcome Measure Information:
Title
Operative time
Description
calculation of operative time in minutes
Time Frame
intraoperative finding
Title
Presence of detrusor muscle in resected sample
Description
presence of muscle layer in the pathological specimen (Yes/No)
Time Frame
one day after surgery during pathological evaluation
Title
Resected specimen's edge
Description
tumor free margin (Yes/No)
Time Frame
one day after surgery during pathological evaluation
Title
intraoperative complication: bladder perforation
Description
(Yes/No) bladder perforation
Time Frame
intraoperative
Title
Incidence of obturator reflex
Description
(Yes/No) energy induced obturator reflex
Time Frame
intraoperative
Title
hematuria
Description
(Yes/No)
Time Frame
postoperative complication up to 2 weeks
Title
Post-operative catheterization time in hours
Description
time till catheter removal in days
Time Frame
postoperative complication up to 2 weeks
Title
Postoperative irrigation time in hours
Description
hours for the need of postoperative irrigation
Time Frame
postoperative in hours maximum 1 day
Title
Recurrence rate of tumors according to time interval
Description
recurrence of tumor in the follow up cystoscopy
Time Frame
1 year
Title
Recurrence rate of tumors according to tumor location
Description
recurrence of tumor in the follow up cystoscopy in the same site or in different site
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
11361
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AHMED M HIGAZY
Phone
01002609801
Email
ahmedmaherhigazy@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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