NCT05027412

En Bloc TURBT With Collins Loop vs Conventional TURBT

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hospital Universitario de Fuenlabrada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bladder Cancer
• Bladder Neoplasm
• Bladder Urothelial Carcinoma
• Bladder Cancer Stage
• Urothelial Carcinoma Recurrent

Interventions

Type	Name	Description
DEVICE	En bloc TURBT Collins Loop	En bloc TURBT Collins Loop
DEVICE	Conventional TURBT	Conventional TURBT

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-12-01
• Completion: 2023-06-01
• First posted: 2021-08-30
• Last updated: 2021-08-30

Locations

1 site across 1 country: Spain