En Bloc TURBT With Collins Loop vs Conventional TURBT

Hospital Universitario de Fuenlabrada

Status: Unknown

Conditions: Bladder Cancer Stage; Bladder Cancer; Bladder Neoplasm; Urothelial Carcinoma Recurrent; Bladder Urothelial Carcinoma

Treatments: Device: En bloc TURBT Collins Loop; Device: Conventional TURBT

Study type: Interventional

Funder types: Other

Identifiers

NCT05027412

URO

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

En Bloc TURBT with Collins Loop

Experimental group

Description:

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.

Treatment:

Device: En bloc TURBT Collins Loop

Conventional TURBT

Active Comparator group

Description:

The TURB will be carried out with bipolar current according to the traditional technique.

Treatment:

Device: Conventional TURBT