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

NCT04576286 | Completed Phase 2 DMC

• 1 other identifier: FMASU R32/2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Bladder Neoplasm

Keywords

urinary bladder tumors; en bloc resection; holmium laser; bipolar; TURBT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Operative time

  intraoperative finding

• Presence of detrusor muscle in resected sample

  one day after surgery during pathological evaluation

• Resected specimen's edge

  one day after surgery during pathological evaluation

• intraoperative complication: bladder perforation

  intraoperative

• Incidence of obturator reflex

  intraoperative

Study Arms (2)

Holmium en bloc resection

EXPERIMENTAL

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

bipolar en bloc resection

ACTIVE COMPARATOR

bipolar en bloc tumor resection of urinary bladder tumors

Procedure: Holmium versus Bipolar en bloc transurethral resection

Interventions

Holmium versus Bipolar en bloc transurethral resection 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.

Holmium en bloc resection; bipolar en bloc resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11361, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to the type of intervention as well as the data collector and the statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 6, 2020
• Study Start: July 24, 2020
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

EG (1)