En Bloc TURBT With Collins Loop vs Conventional TURBT

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

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

Conditions
-----------------
Urothelial Carcinoma Recurrent, Bladder Cancer, Bladder Neoplasm, Bladder Urothelial Carcinoma, Bladder Cancer Stage

Intervention / Treatment
-----------------
* Device: En bloc TURBT Collins Loop
* Device: Conventional TURBT


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: En Bloc TURBT with Collins Loop<br>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. | Device: En bloc TURBT Collins Loop<br>* En bloc TURBT Collins Loop<br>|
| Active Comparator: Conventional TURBT<br>The TURB will be carried out with bipolar current according to the traditional technique. | Device: Conventional TURBT<br>* Conventional TURBT<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of detrusor muscle in the resected sample | yes/no | 1 year of follow up |