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Clinical Trials/NCT05027412
NCT05027412UnknownNot Applicable

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

Hospital Universitario de Fuenlabrada2 sites in 1 country80 target enrollmentStarted: April 1, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
80
Locations
2
Primary Endpoint
presence of detrusor muscle in the resected sample
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Berta Nasarre

Attending Physician

Hospital Universitario de Fuenlabrada

Study Sites (2)

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