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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| En Bloc TURBT with Collins Loop | Experimental | 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. |
|
| Conventional TURBT | Active Comparator | The TURB will be carried out with bipolar current according to the traditional technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| En bloc TURBT Collins Loop | Device | En bloc TURBT Collins Loop |
| |
| Measure | Description | Time Frame |
|---|---|---|
| presence of detrusor muscle in the resected sample | yes/no | 1 year of follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| emilio A ripalda, MD | Contact | +34916006000 | 6185 | emilio.ripalda@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| emilio f ripalda, MD | Hospital Universitario de Fuenlabrada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Fuenlabrada | Recruiting | Fuenlabrada | Madrid | 28942 | Spain |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Conventional TURBT |
| Device |
Conventional TURBT |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |