En Bloc TURBT With Collins Loop vs Conventional TURBT

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05027412

Acronym

TURBT

Enrollment

Registered

2021-08-30

Start date

2021-04-01

Completion date

2023-06-30

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DEVICEEn bloc TURBT Collins Loop

En bloc TURBT Collins Loop

DEVICEConventional TURBT

Conventional TURBT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
presence of detrusor muscle in the resected sample	1 year of follow up	yes/no

Countries

Spain

Contacts

Primary Contactemilio A ripalda, MD

emilio.ripalda@salud.madrid.org+34916006000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026