En Bloc TURBT With Collins Loop vs Conventional TURBT

  • STATUS
    Recruiting
  • End date
    Jun 6, 2023
  • participants needed
    80
  • sponsor
    Hospital Universitario de Fuenlabrada
Updated on 6 September 2021
cystoscopy
bladder tumor

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

Details
Condition carcinoma of the bladder, Bladder Disorders, Urothelial Cancer, Transitional Cell Carcinoma of the Bladder, bladder disorder, bladder cancer stage, Bladder Urothelial Carcinoma, urinary tract neoplasm, Bladder Carcinoma, Urothelial Carcinoma Recurrent, recurrent urothelial carcinoma, bladder tumor, Bladder Cancer, transitional cell carcinoma of bladder, Urologic Cancer, bladder cancer, bladder neoplasm
Treatment Conventional TURBT, En bloc TURBT Collins Loop
Clinical Study IdentifierNCT05027412
SponsorHospital Universitario de Fuenlabrada
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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