- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03849820
Open vs Robotic Assisted Partial Nephrectomy (OpeRa)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Düsseldorf, Germany, 40225
- Department of Urology, University Hospital Düsseldorf
-
Essen, Germany, 45131
- Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid
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Freiburg, Germany, 79106
- Department of Urology, University Hospital Freiburg
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Halle, Germany, 06120
- Universitätsklinik und Poliklinik für Urologie
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Heidelberg, Germany, 69120
- Universitätsklinikum Heidelberg, Urologische Klinik
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Herne, Germany, 44625
- Klinik für Urologie, Marien Hospital Herne
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Homburg, Germany, 66421
- Department of Urology - Universitätsklinikum des Saarlandes
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Jena, Germany, 07747
- Department of Urology, University Hospital Jena
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Marl, Germany, 45768
- Klinik für Urologie, Marien-Hospital Marl
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Munich, Germany, 81675
- Department of Urology, Klinikum rechts der Isar der Technischen Universität
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Tübingen, Germany, 72076
- Dept. of Urology, University Hospital Tübingen
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Wuppertal, Germany, 42283
- Helios Universitätsklinkum Wuppertal - Department of Urology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Robotic-assisted partial nephrectomy
da Vinci surgical robotic assisted partial nephrectomy
|
Application of the da Vinci surgical robot to assist the partial nephrectomy
Other Names:
|
Active Comparator: Open partial nephrectomy
Open partial nephrectomy surgery
|
Open surgery to conduct the partial nephrectomy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30 day complications
Time Frame: Day of surgery to 30th post operative day
|
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
Time Frame: Day of surgery
|
Timing of surgical steps in the OR
|
Day of surgery
|
Ischemia time
Time Frame: Day of surgery
|
Period in which the kidney has no blood supply
|
Day of surgery
|
Surgical radicality conversions
Time Frame: Day of surgery
|
Conversion from robotic to open, partial to radical
|
Day of surgery
|
Intraoperative blood loss
Time Frame: Day of surgery
|
Volume of blood loss during the surgical procedure
|
Day of surgery
|
Pain assessment
Time Frame: Baseline until Day 90
|
Assessment of pain level via the Brief Pain Inventory (BPI)
|
Baseline until Day 90
|
Pain Medication
Time Frame: Baseline until Day 90
|
Recording pain medication
|
Baseline until Day 90
|
Neuropathic pain
Time Frame: Baseline and Day 30 and Day 90
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Development of neuropathic pain via the DN-4 Patient interview questions
|
Baseline and Day 30 and Day 90
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Kidney function via the estimated glomerular filtration rate (eGRF)
Time Frame: Baseline until Day 5 / discharge (whatever is earlier)
|
Data will be gathered from routine examination, not a mandatory assessment
|
Baseline until Day 5 / discharge (whatever is earlier)
|
Post operative complications
Time Frame: Day 90
|
Any Clavien-Dindo I-V post-operative complication
|
Day 90
|
Length of stay
Time Frame: Discharge
|
Time from surgery to discharge
|
Discharge
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Procedure related readmissions
Time Frame: Day 90
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Readmission that can be linked to the partial nephrectomy
|
Day 90
|
Procedure related reoperations
Time Frame: Day 90
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Re-operation that can be linked to the partial nephrectomy
|
Day 90
|
Quality of recovery from the intervention
Time Frame: Baseline until Day 5 / discharge (whatever is earlier)
|
Quality of recovery questionnaire QoR-9
|
Baseline until Day 5 / discharge (whatever is earlier)
|
Quality of life questionnaire, generic measure
Time Frame: Baseline until Day 90
|
EQ-5D 5L
|
Baseline until Day 90
|
Quality of life questionnaire, cancer patient specific
Time Frame: Baseline until Day 90
|
EORTC QLQ-C30
|
Baseline until Day 90
|
Overall survival
Time Frame: Day of surgery to 5 years
|
time from surgery to death from any cause
|
Day of surgery to 5 years
|
Disease specific survival
Time Frame: Day of surgery to 5 years
|
time from surgery to death due to kidney cancer
|
Day of surgery to 5 years
|
Disease free survival
Time Frame: Day of surgery to 5 years
|
time from surgery to first documented recurrence of renal cell carcinoma as defined by the investigator
|
Day of surgery to 5 years
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Local recurrence free survival
Time Frame: Day of surgery to 5 years
|
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
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Comprehensive Complication Index
Time Frame: Day of surgery to 30th post operative day
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Any complication that occurred within 30 days post surgery
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Day of surgery to 30th post operative day
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Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OpeRa-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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