Open vs Robotic Assisted Partial Nephrectomy (OpeRa)

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.

Study Overview

• Status: Terminated
• Conditions: Renal Cancer
• Intervention / Treatment: Device: Robotic-assisted partial nephrectomy; Other: Open partial nephrectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Department of Urology, University Hospital Düsseldorf
  • Essen, Germany, 45131
    • Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid
  • Freiburg, Germany, 79106
    • Department of Urology, University Hospital Freiburg
  • Halle, Germany, 06120
    • Universitätsklinik und Poliklinik für Urologie
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg, Urologische Klinik
  • Herne, Germany, 44625
    • Klinik für Urologie, Marien Hospital Herne
  • Homburg, Germany, 66421
    • Department of Urology - Universitätsklinikum des Saarlandes
  • Jena, Germany, 07747
    • Department of Urology, University Hospital Jena
  • Marl, Germany, 45768
    • Klinik für Urologie, Marien-Hospital Marl
  • Munich, Germany, 81675
    • Department of Urology, Klinikum rechts der Isar der Technischen Universität
  • Tübingen, Germany, 72076
    • Dept. of Urology, University Hospital Tübingen
  • Wuppertal, Germany, 42283
    • Helios Universitätsklinkum Wuppertal - Department of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: Marc O Grimm, MD, Prof, Department of Urology, University Hospital Jena; Principal Investigator: Arnulf Stenzl, MD, Prof, Dept. of Urology, University Hospital Tübingen, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): October 25, 2022

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: minimal invasive surgery; Partial Nephrectomy; RAS; Robotic-assisted Surgery; Open Surgery; MIS
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Kidney Neoplasms
• Other Study ID Numbers: OpeRa-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes