Clinical trial · Interventional
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
NCT05027412CI-TRIAL-00053573TURBTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Cancer Stage | — | UNRESOLVED | — |
| Bladder Neoplasm | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Bladder Urothelial Carcinoma | Bladder Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Urothelial Carcinoma Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional TURBT | Device | — | UNRESOLVED |
| En bloc TURBT Collins Loop | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- En Bloc TURBT with Collins Loop
- 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.
- interventionNames
- Device: En bloc TURBT Collins Loop
- type
- ACTIVE_COMPARATOR
- label
- Conventional TURBT
- description
- The TURB will be carried out with bipolar current according to the traditional technique.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.