Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2021-04-01
2023-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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En Bloc TURBT with Collins Loop
If the patient is randomized to the TURB group, it will be carried out with a Collins loop, with bipolar energy.
After randomization, demographic data (age, sex, exposure to tobacco, occupational risk), symptoms prior to randomization (micro or macrohematuria, LUTS) and laboratory data (urinary cytology, hemoglobin and serum creatinine) will be collected. Finally, the physical characteristics of the lesion will be noted in the cystoscopy immediately prior to the intervention: size, location (s) and appearance of the tumor. After the intervention, the type of procedure (TURB / TUB), the duration of the procedure from when the resector is inserted until the urinary catheter is placed, and complications according to the Clavien-Dindo scale will be recorded. In your first post-surgical check-up, the days of hospital stay and the time of bladder catheterization will be collected.
En bloc TURBT Collins Loop
En bloc TURBT Collins Loop
Conventional TURBT
The TURB will be carried out with bipolar current according to the traditional technique.
Conventional TURBT
Conventional TURBT
Interventions
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En bloc TURBT Collins Loop
En bloc TURBT Collins Loop
Conventional TURBT
Conventional TURBT
Eligibility Criteria
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Inclusion Criteria
* Polypoid / sessile primary tumor.
* \< 3 tumors
* Tumor size 10 - 30 mm.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hospital Universitario de Fuenlabrada
OTHER
Responsible Party
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Berta Nasarre
Attending Physician
Principal Investigators
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emilio f ripalda, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de Fuenlabrada
Locations
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Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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URO
Identifier Type: -
Identifier Source: org_study_id
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