Transurethral En Bloc Resection With Collins Loop vs Conventional Transurethral Resection for the Treatment of Urothelial Bladder Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Hospital Universitario de Fuenlabrada
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- presence of detrusor muscle in the resected sample
- Last Updated
- 4 years ago
Overview
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.
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
Investigators
Berta Nasarre
Attending Physician
Hospital Universitario de Fuenlabrada
Eligibility Criteria
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.
Outcomes
Primary Outcomes
presence of detrusor muscle in the resected sample
Time Frame: 1 year of follow up
yes/no