Open vs Robotic Assisted Partial Nephrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Open vs Robotic Assisted Partial Nephrectomy

Conditions
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Renal Cancer

Intervention / Treatment
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* Device: Robotic-assisted partial nephrectomy
* Other: Open partial nephrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic-assisted partial nephrectomy<br>da Vinci surgical robotic assisted partial nephrectomy | Device: Robotic-assisted partial nephrectomy<br>* Application of the da Vinci surgical robot to assist the partial nephrectomy<br>* Other names: da Vinci, RAS, dVPN;|
| Active Comparator: Open partial nephrectomy<br>Open partial nephrectomy surgery | Other: Open partial nephrectomy<br>* Open surgery to conduct the partial nephrectomy<br>* Other names: Open surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day complications | Any complication that occurred within 30 days post surgery | Day of surgery to 30th post operative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Timing of surgical steps in the OR | Day of surgery | 
| Ischemia time | Period in which the kidney has no blood supply | Day of surgery | 
| Surgical radicality conversions | Conversion from robotic to open, partial to radical | Day of surgery | 
| Intraoperative blood loss | Volume of blood loss during the surgical procedure | Day of surgery | 
| Pain assessment | Assessment of pain level via the Brief Pain Inventory (BPI) | Baseline until Day 90 | 
| Pain Medication | Recording pain medication | Baseline until Day 90 | 
| Neuropathic pain | Development of neuropathic pain via the DN-4 Patient interview questions | Baseline and Day 30 and Day 90 | 
| Kidney function via the estimated glomerular filtration rate (eGRF) | Data will be gathered from routine examination, not a mandatory assessment | Baseline until Day 5 / discharge (whatever is earlier) | 
| Post operative complications | Any Clavien-Dindo I-V post-operative complication | Day 90 | 
| Length of stay | Time from surgery to discharge | Discharge | 
| Procedure related readmissions | Readmission that can be linked to the partial nephrectomy | Day 90 | 
| Procedure related reoperations | Re-operation that can be linked to the partial nephrectomy | Day 90 | 
| Quality of recovery from the intervention | Quality of recovery questionnaire QoR-9 | Baseline until Day 5 / discharge (whatever is earlier) | 
| Quality of life questionnaire, generic measure | EQ-5D 5L | Baseline until Day 90 | 
| Quality of life questionnaire, cancer patient specific | EORTC QLQ-C30 | Baseline until Day 90 | 
| Overall survival | time from surgery to death from any cause | Day of surgery to 5 years | 
| Disease specific survival | time from surgery to death due to kidney cancer | Day of surgery to 5 years | 
| Disease free survival | time from surgery to first documented recurrence of renal cell carcinoma as defined by the investigator | Day of surgery to 5 years | 
| Local recurrence free survival | 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. | Day of surgery to 5 years | 
| Comprehensive Complication Index | Any complication that occurred within 30 days post surgery | Day of surgery to 30th post operative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic-assisted Surgery, Open Surgery, Partial Nephrectomy, minimal invasive surgery, RAS, MIS