Open vs Robotic Assisted Partial Nephrectomy
- Conditions
- Renal Cancer
- Interventions
- Device: Robotic-assisted partial nephrectomyOther: Open partial nephrectomy
- Registration Number
- NCT03849820
- Lead Sponsor
- Intuitive Surgical
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 247
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robotic-assisted partial nephrectomy Robotic-assisted partial nephrectomy da Vinci surgical robotic assisted partial nephrectomy Open partial nephrectomy Open partial nephrectomy Open partial nephrectomy surgery
- Primary Outcome Measures
Name Time Method 30 day complications Day of surgery to 30th post operative day Any complication that occurred within 30 days post surgery
- Secondary Outcome Measures
Name Time Method Ischemia time Day of surgery Period in which the kidney has no blood supply
Pain assessment Baseline until Day 90 Assessment of pain level via the Brief Pain Inventory (BPI)
Pain Medication Baseline until Day 90 Recording pain medication
Kidney function via the estimated glomerular filtration rate (eGRF) Baseline until Day 5 / discharge (whatever is earlier) Data will be gathered from routine examination, not a mandatory assessment
Surgical radicality conversions Day of surgery Conversion from robotic to open, partial to radical
Overall survival Day of surgery to 5 years time from surgery to death from any cause
Neuropathic pain Baseline and Day 30 and Day 90 Development of neuropathic pain via the DN-4 Patient interview questions
Disease free survival Day of surgery to 5 years time from surgery to first documented recurrence of renal cell carcinoma as defined by the investigator
Operative time Day of surgery Timing of surgical steps in the OR
Intraoperative blood loss Day of surgery Volume of blood loss during the surgical procedure
Post operative complications Day 90 Any Clavien-Dindo I-V post-operative complication
Procedure related readmissions Day 90 Readmission that can be linked to the partial nephrectomy
Procedure related reoperations Day 90 Re-operation that can be linked to the partial nephrectomy
Quality of recovery from the intervention Baseline until Day 5 / discharge (whatever is earlier) Quality of recovery questionnaire QoR-9
Comprehensive Complication Index Day of surgery to 30th post operative day Any complication that occurred within 30 days post surgery
Length of stay Discharge Time from surgery to discharge
Quality of life questionnaire, generic measure Baseline until Day 90 EQ-5D 5L
Quality of life questionnaire, cancer patient specific Baseline until Day 90 EORTC QLQ-C30
Disease specific survival Day of surgery to 5 years time from surgery to death due to kidney cancer
Local recurrence free survival Day of surgery to 5 years Time from surgery to the first documented local recurrence e.g. tumor in the operated kidney or in the immediate vicinity (e.g. perirenal fat) at the surgical site. Portside recurrence / incisional, surgical access site recurrence to the affected kidney would also be considered as a local recurrence.
Trial Locations
- Locations (12)
Department of Urology, University Hospital Jena
🇩🇪Jena, Germany
Department of Urology, University Hospital Düsseldorf
🇩🇪Düsseldorf, Germany
Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid
🇩🇪Essen, Germany
Universitätsklinik und Poliklinik für Urologie
🇩🇪Halle, Germany
Department of Urology, University Hospital Freiburg
🇩🇪Freiburg, Germany
Universitätsklinikum Heidelberg, Urologische Klinik
🇩🇪Heidelberg, Germany
Klinik für Urologie, Marien-Hospital Marl
🇩🇪Marl, Germany
Klinik für Urologie, Marien Hospital Herne
🇩🇪Herne, Germany
Department of Urology - Universitätsklinikum des Saarlandes
🇩🇪Homburg, Germany
Department of Urology, Klinikum rechts der Isar der Technischen Universität
🇩🇪Munich, Germany
Dept. of Urology, University Hospital Tübingen
🇩🇪Tübingen, Germany
Helios Universitätsklinkum Wuppertal - Department of Urology
🇩🇪Wuppertal, Germany