En Bloc TURBT With Collins Loop vs Conventional TURBT

Sponsor

Hospital Universitario de Fuenlabrada (Other)

Overall Status

Recruiting

CT.gov ID

NCT05027412

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Bladder Neoplasm Bladder Urothelial Carcinoma Bladder Cancer Stage Urothelial Carcinoma Recurrent	Device: En bloc TURBT Collins Loop Device: Conventional TURBT	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Transurethral En Bloc Resection With Collins Loop vs Conventional Transurethral Resection for the Treatment of Urothelial Bladder Carcinoma

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: En Bloc TURBT with Collins Loop 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.	Device: En bloc TURBT Collins Loop En bloc TURBT Collins Loop
Active Comparator: Conventional TURBT The TURB will be carried out with bipolar current according to the traditional technique.	Device: Conventional TURBT Conventional TURBT

Arm

Intervention/Treatment

Experimental: En Bloc TURBT with Collins Loop

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.

Device: En bloc TURBT Collins Loop

En bloc TURBT Collins Loop

Active Comparator: Conventional TURBT

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

Device: Conventional TURBT

Conventional TURBT

Outcome Measures

Primary Outcome Measures

presence of detrusor muscle in the resected sample [1 year of follow up]
yes/no

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid	Spain	28942

Sponsors and Collaborators

Hospital Universitario de Fuenlabrada

Investigators

Principal Investigator: emilio f ripalda, MD, Hospital Universitario de Fuenlabrada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Berta Nasarre, Attending Physician, Hospital Universitario de Fuenlabrada

ClinicalTrials.gov Identifier:

NCT05027412

Other Study ID Numbers:

First Posted:

Aug 30, 2021

Last Update Posted:

Aug 30, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Study Results

No Results Posted as of Aug 30, 2021