Open vs Robotic Assisted Partial Nephrectomy

Intuitive Surgical247 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

247

Conditions

Renal Cancer

Interventions

Robotic-assisted partial nephrectomyDEVICE

Application of the da Vinci surgical robot to assist the partial nephrectomy

Open partial nephrectomyOTHER

Open surgery to conduct the partial nephrectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Dept. of Urology, University Hospital Tübingen

Tübingen, Germany, Germany

Department of Urology, University Hospital Düsseldorf

Düsseldorf, Germany

Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid

Essen, Germany

Outcomes

Primary Outcomes

30 day complications

Any complication that occurred within 30 days post surgery

Time frame: Day of surgery to 30th post operative day

Secondary Outcomes

Operative time

Timing of surgical steps in the OR

Time frame: Day of surgery

Ischemia time

Period in which the kidney has no blood supply

Time frame: Day of surgery

Surgical radicality conversions

Conversion from robotic to open, partial to radical

Time frame: Day of surgery

Intraoperative blood loss

Volume of blood loss during the surgical procedure

Time frame: Day of surgery

Pain assessment

Assessment of pain level via the Brief Pain Inventory (BPI)

Time frame: Baseline until Day 90

Pain Medication

Recording pain medication

Time frame: Baseline until Day 90

Neuropathic pain

Development of neuropathic pain via the DN-4 Patient interview questions

Time frame: 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

Data from ClinicalTrials.gov

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