Renal CancerOpeRaNCT03849820
Open vs Robotic Assisted Partial Nephrectomy
A study testing Robotic-assisted partial nephrectomy and Open partial nephrectomy in people with Renal Cancer, run by Intuitive Surgical at 12 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer
- What is being tested?
- Robotic-assisted partial nephrectomy and Open partial nephrectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 12 sitesGermany
- Study dates
- 12 Mar 2019to 25 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Department of Urology, University Hospital Düsseldorf
Düsseldorf, 40225
Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid
Essen, 45131
Department of Urology, University Hospital Freiburg
Freiburg im Breisgau, 79106
Universitätsklinik und Poliklinik für Urologie
Halle, 06120
Universitätsklinikum Heidelberg, Urologische Klinik
Heidelberg, 69120
Klinik für Urologie, Marien Hospital Herne
Herne, 44625
Department of Urology - Universitätsklinikum des Saarlandes
Homburg, 66421
Department of Urology, University Hospital Jena
Jena, 07747
Klinik für Urologie, Marien-Hospital Marl
Marl, 45768
Department of Urology, Klinikum rechts der Isar der Technischen Universität
Munich, 81675
Dept. of Urology, University Hospital Tübingen
Tübingen, Germany, 72076
Helios Universitätsklinkum Wuppertal - Department of Urology
Wuppertal, 42283
About this study
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.
Read the 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.
- Conditions
- Renal Cancer
- Being tested
- Robotic-assisted partial nephrectomy, Open partial nephrectomy
- Keywords
- Robotic-assisted Surgery, Open Surgery, Partial Nephrectomy, minimal invasive surgery, RAS, MIS
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted partial nephrectomyDevice
Also called da Vinci, RAS, dVPN
Application of the da Vinci surgical robot to assist the partial nephrectomy
Open partial nephrectomyOther
Also called Open surgery
Open surgery to conduct the partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted partial nephrectomy | Active comparator | da Vinci surgical robotic assisted partial nephrectomy Receives: Device: Robotic-assisted partial nephrectomy |
| Open partial nephrectomy | Active comparator | Open partial nephrectomy surgery Receives: Other: Open partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day complications
Any complication that occurred within 30 days post surgery
Measured: Day of surgery to 30th post operative day
Secondary outcomes (20)
Operative time
Timing of surgical steps in the OR
Measured: Day of surgery
Ischemia time
Period in which the kidney has no blood supply
Measured: Day of surgery
Surgical radicality conversions
Conversion from robotic to open, partial to radical
Measured: Day of surgery
Intraoperative blood loss
Volume of blood loss during the surgical procedure
Measured: Day of surgery
Pain assessment
Assessment of pain level via the Brief Pain Inventory (BPI)
Measured: Baseline until Day 90
Pain Medication
Recording pain medication
Measured: Baseline until Day 90
Neuropathic pain
Development of neuropathic pain via the DN-4 Patient interview questions
Measured: 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
Measured: Baseline until Day 5 / discharge (whatever is earlier)
Post operative complications
Any Clavien-Dindo I-V post-operative complication
Measured: Day 90
Length of stay
Time from surgery to discharge
Measured: Discharge
Procedure related readmissions
Readmission that can be linked to the partial nephrectomy
Measured: Day 90
Procedure related reoperations
Re-operation that can be linked to the partial nephrectomy
Measured: Day 90
Quality of recovery from the intervention
Quality of recovery questionnaire QoR-9
Measured: Baseline until Day 5 / discharge (whatever is earlier)
Quality of life questionnaire, generic measure
EQ-5D 5L
Measured: Baseline until Day 90
Quality of life questionnaire, cancer patient specific
EORTC QLQ-C30
Measured: Baseline until Day 90
Overall survival
time from surgery to death from any cause
Measured: Day of surgery to 5 years
Disease specific survival
time from surgery to death due to kidney cancer
Measured: 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
Measured: 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.
Measured: Day of surgery to 5 years
Comprehensive Complication Index
Any complication that occurred within 30 days post surgery
Measured: Day of surgery to 30th post operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start12 Mar 2019
- Primary completion15 Dec 2021
- Study completion25 Oct 2022
Why it stopped: Due to low enrollment the study was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc O Grimm, MD, Prof, Principal investigator, Department of Urology, University Hospital JenaArnulf Stenzl, MD, Prof, Principal investigator, Dept. of Urology, University Hospital Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849820
- Sponsor's protocol ID
- OpeRa-2018
- Acronym
- OpeRa
- Status last verified
- Apr 2025
- First submitted
- 15 Feb 2019
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 Aug;36(8):988-998. doi: 10.1016/j.annonc.2025.04.005. Epub 2025 Apr 16.
PubMed 40250528
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open vs Robotic Assisted Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT03849820
- Acronym / sponsor ID
- OpeRa / OpeRa-2018
- Conditions
- Renal Cancer
- Keywords
- Robotic-assisted Surgery, Open Surgery, Partial Nephrectomy, minimal invasive surgery, RAS, MIS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low enrollment the study was terminated
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted partial nephrectomy | Active comparator | Device: Robotic-assisted partial nephrectomyda Vinci surgical robotic assisted partial nephrectomy |
| Open partial nephrectomy | Active comparator | Other: Open partial nephrectomyOpen partial nephrectomy surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted partial nephrectomyAlso: da Vinci, RAS, dVPNApplication of the da Vinci surgical robot to assist the partial nephrectomy | Device | Robotic-assisted partial nephrectomy |
| Open partial nephrectomyAlso: Open surgeryOpen surgery to conduct the partial nephrectomy | Other | Open partial nephrectomy |
Primary outcome
30 day complications
Time frame: Day of surgery to 30th post operative day
Any complication that occurred within 30 days post surgery
20 secondary outcomes
Operative time
Time frame: Day of surgery
Ischemia time
Time frame: Day of surgery
Surgical radicality conversions
Time frame: Day of surgery
Intraoperative blood loss
Time frame: Day of surgery
Pain assessment
Time frame: Baseline until Day 90
Pain Medication
Time frame: Baseline until Day 90
Neuropathic pain
Time frame: Baseline and Day 30 and Day 90
Kidney function via the estimated glomerular filtration rate (eGRF)
Time frame: Baseline until Day 5 / discharge (whatever is earlier)
Post operative complications
Time frame: Day 90
Length of stay
Time frame: Discharge
Procedure related readmissions
Time frame: Day 90
Procedure related reoperations
Time frame: Day 90
Quality of recovery from the intervention
Time frame: Baseline until Day 5 / discharge (whatever is earlier)
Quality of life questionnaire, generic measure
Time frame: Baseline until Day 90
Quality of life questionnaire, cancer patient specific
Time frame: Baseline until Day 90
Overall survival
Time frame: Day of surgery to 5 years
Disease specific survival
Time frame: Day of surgery to 5 years
Disease free survival
Time frame: Day of surgery to 5 years
Local recurrence free survival
Time frame: Day of surgery to 5 years
Comprehensive Complication Index
Time frame: Day of surgery to 30th post operative day
Results and safety
The study was stopped early (reason given: Due to low enrollment the study was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Results publication: PubMed 40250528Grimm 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 Aug;36(8):988-998. doi: 10.1016/j.annonc.2025.04.005. Epub 2025 Apr 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc O Grimm, MD, Prof principal investigator
Department of Urology, University Hospital Jena
Arnulf Stenzl, MD, Prof principal investigator
Dept. of Urology, University Hospital Tübingen, Germany
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted partial nephrectomy and Open partial nephrectomy in people with Renal Cancer, run by Intuitive Surgical at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to low enrollment the study was terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day complications (time frame: Day of surgery to 30th post operative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03849820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.