En Bloc TURBT With Collins Loop vs Conventional TURBT

NCT05027412 | Unknown

• 1 other identifier: URO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Bladder Neoplasm; Bladder Urothelial Carcinoma; Bladder Cancer Stage; Urothelial Carcinoma Recurrent

Outcome Measures

Primary Outcomes (1)

• presence of detrusor muscle in the resected sample

  yes/no

  1 year of follow up

Study Arms (2)

En Bloc TURBT with Collins Loop

EXPERIMENTAL

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

Conventional TURBT

ACTIVE COMPARATOR

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

Device: Conventional TURBT

Interventions

En bloc TURBT Collins Loop DEVICE

En bloc TURBT Collins Loop

En Bloc TURBT with Collins Loop

Conventional TURBT DEVICE

Conventional TURBT

Conventional TURBT

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• Hospital Universitario de Fuenlabrada: lead

Study Sites (1)

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

RECRUITING

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 Officials

• emilio f ripalda, MD

  Hospital Universitario de Fuenlabrada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

emilio A ripalda, MD

CONTACT

+34916006000; emilio.ripalda@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 30, 2021
• Study Start: April 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)