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En Bloc TURBT With Collins Loop vs Conventional TURBT (TURBT)

Primary Purpose

Bladder Cancer, Bladder Neoplasm, Bladder Urothelial Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
En bloc TURBT Collins Loop
Conventional TURBT
Sponsored by
Hospital Universitario de Fuenlabrada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • >18 years old.
  • Polypoid / sessile primary tumor.
  • < 3 tumors
  • Tumor size 10 - 30 mm.

Exclusion Criteria:

  • > 4 tumors
  • Size of the largest tumor <1 cm and> 4 cm.
  • Tumor located in the bladder dome.
  • No visualization of the ureteral meatus.
  • Flat or in situ tumor.
  • Non-urothelial tumors.
  • Clotting disorder or treatment with oral anticoagulants.

Sites / Locations

  • Hospital Universitario de FuenlabradaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

En Bloc TURBT with Collins Loop

Conventional TURBT

Arm Description

If the patient is randomized to the TURB group, it will be carried out with a Collins loop, with bipolar energy. After randomization, demographic data (age, sex, exposure to tobacco, occupational risk), symptoms prior to randomization (micro or macrohematuria, LUTS) and laboratory data (urinary cytology, hemoglobin and serum creatinine) will be collected. Finally, the physical characteristics of the lesion will be noted in the cystoscopy immediately prior to the intervention: size, location (s) and appearance of the tumor. After the intervention, the type of procedure (TURB / TUB), the duration of the procedure from when the resector is inserted until the urinary catheter is placed, and complications according to the Clavien-Dindo scale will be recorded. In your first post-surgical check-up, the days of hospital stay and the time of bladder catheterization will be collected.

The TURB will be carried out with bipolar current according to the traditional technique.

Outcomes

Primary Outcome Measures

presence of detrusor muscle in the resected sample
yes/no

Secondary Outcome Measures

Full Information

First Posted
August 24, 2021
Last Updated
August 24, 2021
Sponsor
Hospital Universitario de Fuenlabrada
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1. Study Identification

Unique Protocol Identification Number
NCT05027412
Brief Title
En Bloc TURBT With Collins Loop vs Conventional TURBT
Acronym
TURBT
Official Title
Transurethral En Bloc Resection With Collins Loop vs Conventional Transurethral Resection for the Treatment of Urothelial Bladder Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario de Fuenlabrada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, randomized, randomized and single-blind study in patients diagnosed with primary bladder CV. Patients diagnosed by cystoscopy of a bladder tumor and with indication for endoscopic surgical treatment, who meet the inclusion criteria, and who sign the Informed Consent (IC), will be randomized.
Detailed Description
The main objective of the study is to assess the quality of the resection, defined as the presence of detrusor muscle in the resected tissue. The secondary objetives are: Compare the surgical time, hospital stay, urinary catheterization time and incidence of complications. Compare tumor recurrence after one year of follow up. Determine the number of re-TURB as a consequence of the absence of muscle layer in the sample or artifacts (Tx) Establish the incidence of conversions as a consequence of difficulties in the technique or intraoperative bleeding. Compare the degree of satisfaction of the surgeon

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Bladder Neoplasm, Bladder Urothelial Carcinoma, Bladder Cancer Stage, Urothelial Carcinoma Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
En Bloc TURBT with Collins Loop
Arm Type
Experimental
Arm Description
If the patient is randomized to the TURB group, it will be carried out with a Collins loop, with bipolar energy. After randomization, demographic data (age, sex, exposure to tobacco, occupational risk), symptoms prior to randomization (micro or macrohematuria, LUTS) and laboratory data (urinary cytology, hemoglobin and serum creatinine) will be collected. Finally, the physical characteristics of the lesion will be noted in the cystoscopy immediately prior to the intervention: size, location (s) and appearance of the tumor. After the intervention, the type of procedure (TURB / TUB), the duration of the procedure from when the resector is inserted until the urinary catheter is placed, and complications according to the Clavien-Dindo scale will be recorded. In your first post-surgical check-up, the days of hospital stay and the time of bladder catheterization will be collected.
Arm Title
Conventional TURBT
Arm Type
Active Comparator
Arm Description
The TURB will be carried out with bipolar current according to the traditional technique.
Intervention Type
Device
Intervention Name(s)
En bloc TURBT Collins Loop
Intervention Description
En bloc TURBT Collins Loop
Intervention Type
Device
Intervention Name(s)
Conventional TURBT
Intervention Description
Conventional TURBT
Primary Outcome Measure Information:
Title
presence of detrusor muscle in the resected sample
Description
yes/no
Time Frame
1 year of follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 years old. Polypoid / sessile primary tumor. < 3 tumors Tumor size 10 - 30 mm. Exclusion Criteria: > 4 tumors Size of the largest tumor <1 cm and> 4 cm. Tumor located in the bladder dome. No visualization of the ureteral meatus. Flat or in situ tumor. Non-urothelial tumors. Clotting disorder or treatment with oral anticoagulants.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
emilio A ripalda, MD
Phone
+34916006000
Ext
6185
Email
emilio.ripalda@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
emilio f ripalda, MD
Organizational Affiliation
Hospital Universitario de Fuenlabrada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Otaola Arca, M.D., Ph.D.
Phone
+56 9 4108 9452
Email
hugotaolarca@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hugo Otaola Arca, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Manuel Álvarez Ardura, M.D.
First Name & Middle Initial & Last Name & Degree
Álvaro Páez Borda, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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En Bloc TURBT With Collins Loop vs Conventional TURBT

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