En Bloc TURBT With Collins Loop vs Conventional TURBT

Bladder Cancer Clinical Trial

— TURBT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05027412
• Other study ID #: URO
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 2023

Study information

• Verified date: August 2021
• Source: Hospital Universitario de Fuenlabrada
• Contact: emilio A ripalda, MD
• Phone: +34916006000
• Email: emilio.ripalda[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Cancer Stage
• Bladder Neoplasm
• Bladder Urothelial Carcinoma
• Carcinoma
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urothelial Carcinoma Recurrent

Intervention

Device:
• En bloc TURBT Collins Loop
En bloc TURBT Collins Loop
• Conventional TURBT
Conventional TURBT

Locations

Country	Name	City	State
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Fuenlabrada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of detrusor muscle in the resected sample	yes/no	1 year of follow up