Open vs Robotic Assisted Partial Nephrectomy (OpeRa)
Status
Conditions
Treatments
Details and patient eligibility
About
To demonstrate that Robotic-Assisted partial nephrectomy is superior to Open partial nephrectomy in reducing the number of 30 day post-operative complications (Clavien-Dindo Type I-V) for patients with intermediate to high complexity kidney tumors.
Full description
Partial nephrectomy is the surgical removal of a kidney tumor while unaffected tissue remains intact so that the kidney function is maintained as far as possible. The more radical procedure would be the complete removal of the kidney, which is not examined in this trial.
Surgery will be randomized either to an open technique involving a large incision or the robotic assisted technique with a few small incisions (keyhole surgery). With robotic assisted surgery the movements of the surgeon are translated into the movement of the instruments.
It is not clear which of the two procedures, open or robotic assisted, has less complications. It is expected that these are different due to the different level of invasiveness and the level of direct access to the organ. This study aims to show that robotic assisted surgery results in less complications than open surgery.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age 18 years or older
- Patient with a renal tumor that is a candidate for OPEN surgery and robotic assisted surgery (RAS) partial nephrectomy (PN)
- R.E.N.A.L. score ≥ 7
- eGFR ≥ 50 ml/min/1.73 m²
- Anticoagulation is accepted according to the surgeon's practice
Exclusion criteria
- Solitary kidney or functionally solitary kidney
- Prior surgery at the affected kidney excluding endoscopic kidney stone surgery
- Bilateral tumors
- Multiple renal tumors requiring excision
- Renal vein tumor thrombus
- Likely insufficient volume of remaining parenchyma after partial nephrectomy to maintain viable kidney remnant
- Metastatic disease with life expectancy of less than 1 year
- Pregnancy or suspected pregnancy
- Planned concomitant procedure
- Subject who is unable or unwilling to comply with the protocol requirements
- Subject considered to be from a vulnerable population according to IS0 14155:2011
Trial design
Primary purpose
Allocation
Interventional model
Masking
247 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal