Surgical technique for bladder tumor removal
En Bloc Bladder Tumor Resection: Prospective Randomized Evaluation of Monopolar, Bipolar and Laser Energy
This study is testing a new surgical method for removing bladder tumors to see if it leads to better recovery and fewer complications for patients with bladder cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacio Puigvert Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04712201 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of en bloc transurethral resection of bladder tumors (TURBT) compared to conventional TURBT in patients with urothelial carcinoma of the bladder. The study aims to improve surgical outcomes by enhancing the quality of tumor specimens for pathological analysis, reducing postoperative complications, and lowering recurrence rates. Patients with unifocal or multifocal bladder cancer, each lesion measuring 3 cm or less, will be included in the trial. The study is designed to provide a prospective randomized comparison of these two surgical techniques.
Who should consider this trial
Good fit: Ideal candidates are patients with unifocal or multifocal bladder cancer, with lesions measuring 3 cm or less.
Not a fit: Patients with more than three tumors or those with muscle-invasive bladder cancer or distant metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better surgical outcomes and lower recurrence rates for bladder cancer patients.
How similar studies have performed: Previous studies have shown that en bloc resection techniques can improve surgical outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unifocal primary or recurrent bladder cancer with size less or equal than 3 cm * Multifocal primary or recurrent bladder cancer less or equal than 3 lesions and with size less or equal than 3 cm Exclusion Criteria: * Evidence of \> 3 tumors or \> 3 cm * Computed tomography/cystoscopy suspect of muscle-invasive bladder cancer (cT2 or higher) * Computed tomography/magnetic resonance evidence of distant metastases
Where this trial is running
Barcelona
- Fundacio Puigvert — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Andrea Gallioli, MD
- Email: agallioli@fundacio-puigvert.es
- Phone: 0034934169730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.