En Bloc TURBT With Collins Loop vs Conventional TURBT

Not Applicable

• Conditions: Bladder Cancer; Bladder Cancer Stage; Bladder Urothelial Carcinoma; Bladder Neoplasm; Urothelial Carcinoma Recurrent
• Interventions: Device: Conventional TURBT; Device: En bloc TURBT Collins Loop

• Registration Number: NCT05027412
• Lead Sponsor: Hospital Universitario de Fuenlabrada

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

Study Timeline

• Study Start: 2021-04-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Last Update Submitted: 2021-08-24
• Study First Posted: 2021-08-30
• Last Update Posted: 2021-08-30
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional TURBT	Conventional TURBT	The TURB will be carried out with bipolar current according to the traditional technique.
En Bloc TURBT with Collins Loop	En bloc TURBT 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.

Primary Outcome Measures

Name	Time	Method
presence of detrusor muscle in the resected sample	1 year of follow up	yes/no

Trial Locations

Locations (1)

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain