Renal Cancer
Conditions
Keywords
Robotic-assisted Surgery, Open Surgery, Partial Nephrectomy, minimal invasive surgery, RAS, MIS
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.
Interventions
DEVICERobotic-assisted partial nephrectomy
Application of the da Vinci surgical robot to assist the partial nephrectomy
Open surgery to conduct the partial nephrectomy
Sponsors
Intuitive Surgical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 day complications | Day of surgery to 30th post operative day | Any complication that occurred within 30 days post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ischemia time | Day of surgery | Period in which the kidney has no blood supply |
| Surgical radicality conversions | Day of surgery | Conversion from robotic to open, partial to radical |
| Intraoperative blood loss | Day of surgery | Volume of blood loss during the surgical procedure |
| 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 |
| Neuropathic pain | Baseline and Day 30 and Day 90 | Development of neuropathic pain via the DN-4 Patient interview questions |
| 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 |
| Post operative complications | Day 90 | Any Clavien-Dindo I-V post-operative complication |
| Length of stay | Discharge | Time from surgery to discharge |
| Operative time | Day of surgery | Timing of surgical steps in the OR |
| 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 |
| 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 |
| Overall survival | Day of surgery to 5 years | time from surgery to death from any cause |
| Disease specific survival | Day of surgery to 5 years | time from surgery to death due to kidney cancer |
| 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 |
| 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. |
| Comprehensive Complication Index | Day of surgery to 30th post operative day | Any complication that occurred within 30 days post surgery |
| Procedure related readmissions | Day 90 | Readmission that can be linked to the partial nephrectomy |
Countries
Germany
Outcome results
None listed