Clinical trial NCT03849820: Open vs Robotic Assisted Partial Nephrectomy
Official title: Open vs Robotic Assisted Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Cancer
Keywords: Robotic-assisted Surgery
Open Surgery
Partial Nephrectomy
minimal invasive surgery
RAS
MIS
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Subject considered to be from a vulnerable population according to IS0 14155:2011

Primary outcomes:
measure: 30 day complications
timeFrame: Day of surgery to 30th post operative day
Secondary outcomes:
measure: Operative time
timeFrame: Day of surgery
measure: Ischemia time
timeFrame: Day of surgery
measure: Surgical radicality conversions
timeFrame: Day of surgery
measure: Intraoperative blood loss
timeFrame: Day of surgery
measure: Pain assessment
timeFrame: Baseline until Day 90
measure: Pain Medication
timeFrame: Baseline until Day 90
measure: Neuropathic pain
timeFrame: Baseline and Day 30 and Day 90
measure: Kidney function via the estimated glomerular filtration rate (eGRF)
timeFrame: Baseline until Day 5 / discharge (whatever is earlier)
measure: Post operative complications
timeFrame: Day 90
measure: Length of stay
timeFrame: Discharge
measure: Procedure related readmissions
timeFrame: Day 90
measure: Procedure related reoperations
timeFrame: Day 90
measure: Quality of recovery from the intervention
timeFrame: Baseline until Day 5 / discharge (whatever is earlier)
measure: Quality of life questionnaire, generic measure
timeFrame: Baseline until Day 90
measure: Quality of life questionnaire, cancer patient specific
timeFrame: Baseline until Day 90
measure: Overall survival
timeFrame: Day of surgery to 5 years
measure: Disease specific survival
timeFrame: Day of surgery to 5 years
measure: Disease free survival
timeFrame: Day of surgery to 5 years
measure: Local recurrence free survival
timeFrame: Day of surgery to 5 years
measure: Comprehensive Complication Index
timeFrame: Day of surgery to 30th post operative day
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Department of Urology, University Hospital Düsseldorf
city: Essen
country: Germany
facility: Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid
city: Freiburg
country: Germany
facility: Department of Urology, University Hospital Freiburg
city: Halle
country: Germany
facility: Universitätsklinik und Poliklinik für Urologie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg, Urologische Klinik
city: Herne
country: Germany
facility: Klinik für Urologie, Marien Hospital Herne
city: Homburg
country: Germany
facility: Department of Urology - Universitätsklinikum des Saarlandes
city: Jena
country: Germany
facility: Department of Urology, University Hospital Jena
city: Marl
country: Germany
facility: Klinik für Urologie, Marien-Hospital Marl
city: Munich
country: Germany
facility: Department of Urology, Klinikum rechts der Isar der Technischen Universität
city: Tübingen
country: Germany
facility: Dept. of Urology, University Hospital Tübingen
city: Wuppertal
country: Germany
facility: Helios Universitätsklinkum Wuppertal - Department of Urology
Study officials:
affiliation: Department of Urology, University Hospital Jena
name: Marc O Grimm, MD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Urology, University Hospital Tübingen, Germany
name: Arnulf Stenzl, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grimm MO, Bedke J, Nyarangi-Dix J, Khoder W, Foller S, Sommerfeld HJ, Giessing M, Heck M, Meissner W, Slee A, Leucht K, von Rundstedt F, Theil G, Buse S, Siemer S, Albers P, Gratzke C, Hohenfellner M, Stenzl A. Open versus robotic-assisted partial nephrectomy in patients with intermediate/high-complexity kidney tumours: final results of the randomised, controlled, open-label, multicentre trial OpeRa. Ann Oncol. 2025 Apr 16:S0923-7534(25)00159-0. doi: 10.1016/j.annonc.2025.04.005. Online ahead of print.