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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Urothelial Carcinoma Recurrent; Bladder Urothelial Carcinoma; Bladder Neoplasm; Bladder Cancer Stage
• Intervention / Treatment: Device: En bloc TURBT Collins Loop; Device: Conventional TURBT

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: emilio A ripalda, MD; Phone Number: 6185 +34916006000; Email: emilio.ripalda@salud.madrid.org

Study Locations

• Spain
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Recruiting
      • Hospital Universitario de Fuenlabrada
      • Contact: Hugo Otaola Arca, M.D., Ph.D.; Phone Number: +56 9 4108 9452; Email: hugotaolarca@hotmail.com
      • Principal Investigator: Hugo Otaola Arca, M.D., Ph.D.
      • Principal Investigator: Manuel Álvarez Ardura, M.D.
      • Principal Investigator: Álvaro Páez Borda, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence of detrusor muscle in the resected sample	yes/no	1 year of follow up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (ACTUAL): August 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
• Other Study ID Numbers: URO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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