Open vs Robotic Assisted Partial Nephrectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Cancer
- Sponsor
- Intuitive Surgical
- Enrollment
- 247
- Locations
- 12
- Primary Endpoint
- 30 day complications
- Status
- Terminated
- Last Updated
- 10 months ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
30 day complications
Time Frame: Day of surgery to 30th post operative day
Any complication that occurred within 30 days post surgery
Secondary Outcomes
- Ischemia time(Day of surgery)
- Pain assessment(Baseline until Day 90)
- Pain Medication(Baseline until Day 90)
- Kidney function via the estimated glomerular filtration rate (eGRF)(Baseline until Day 5 / discharge (whatever is earlier))
- Surgical radicality conversions(Day of surgery)
- Overall survival(Day of surgery to 5 years)
- Neuropathic pain(Baseline and Day 30 and Day 90)
- Disease free survival(Day of surgery to 5 years)
- Procedure related reoperations(Day 90)
- Quality of recovery from the intervention(Baseline until Day 5 / discharge (whatever is earlier))
- Operative time(Day of surgery)
- Intraoperative blood loss(Day of surgery)
- Post operative complications(Day 90)
- Procedure related readmissions(Day 90)
- Comprehensive Complication Index(Day of surgery to 30th post operative day)
- Length of stay(Discharge)
- Quality of life questionnaire, generic measure(Baseline until Day 90)
- Quality of life questionnaire, cancer patient specific(Baseline until Day 90)
- Disease specific survival(Day of surgery to 5 years)
- Local recurrence free survival(Day of surgery to 5 years)