Prostate Single Port & Laser Enucleation Comparison Trial
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- University of Illinois at Chicago
- Study ID
- NCT06224218
- Status
- Recruiting
Conditions
- Prostate Hyperplasia
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 88 Years
- Healthy Volunteers
- Not accepted
Interventions
- Single Port Robotic Surgery — PROCEDURESingle port Robotic surgery will remove the whole prostate
- Laser Surgery — PROCEDURELaser enucleation will remove chips of the prostate but keeping intact the prostate capsule.
Study Details
Surgical treatments for benign prostatic hyperplasia (BPH) are necessary when non-procedural approaches fail to alleviate lower urinary tract symptoms (LUTS) or bladder outlet obstruction (BOO). Open simple prostatectomy and laser enucleation are recommended for prostatic adenoma size greater than 80 ml. Minimally invasive approaches, such as robotic-assisted simple prostatectomy, have gained popularity due to their comparable outcomes with lower morbidity. The introduction of the da Vinci single-port (SP) robotic platform offers potential advantages, but its outcomes have not been thoroughly investigated. This randomized controlled trial aims to compare the outcomes of SP simple prostatectomy performed using the da Vinci robotic platform versus thulium laser enucleation of the prostate for the treatment of BPH and BOO.
Key Dates
- Start date
- Jan 15, 2024
- Status verified
- May 2024
- Primary completion
- Jan 15, 2027
- Completion
- Aug 15, 2027
Study Design
- Enrollment
- 116 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Single Port Robotic ProstatectomyRemoval of the prostate using single port robot
- Active Comparator: Laser Enucleation of the ProstateEnucleation of the prostate with laser surgery
Primary Outcome Measure
Operative time [ Time Frame: During procedure ]
Central Contacts
- Ruben Sauer, MD3124135288
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UI Health SCB Clinic Department of Urology | Chicago | Illinois | 60612 | Simone Crivellaro, MD (PRINCIPAL_INVESTIGATOR) |
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