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OpeRa: Open vs Robotic Assisted Partial Nephrectomy

Sponsor
Intuitive Surgical (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03849820
Collaborator
(none)
606
Enrollment
12
Locations
2
Arms
107.7
Anticipated Duration (Months)
50.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Robotic-assisted partial nephrectomy
  • Other: Open partial nephrectomy
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
606 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open vs Robotic Assisted Partial Nephrectomy
Actual Study Start Date :
Mar 12, 2019
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Mar 1, 2028

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 30 day complications [Day of surgery to 30th post operative day]

      Any complication that occurred within 30 days post surgery

    Secondary Outcome Measures

    1. Operative time [Day of surgery]

      Timing of surgical steps in the OR

    2. Ischemia time [Day of surgery]

      Period in which the kidney has no blood supply

    3. Surgical radicality conversions [Day of surgery]

      Conversion from robotic to open, partial to radical

    4. Intraoperative blood loss [Day of surgery]

      Volume of blood loss during the surgical procedure

    5. Pain assessment [Baseline until Day 90]

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

    6. Pain Medication [Baseline until Day 90]

      Recording pain medication

    7. Neuropathic pain [Baseline and Day 30 and Day 90]

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

    8. Kidney function via the estimated glomerular filtration rate (eGRF) [Baseline until Day 5 / discharge (whatever is earlier)]

      Data will be gathered from routine examination, not a mandatory assessment

    9. Post operative complications [Day 90]

      Any Clavien-Dindo I-V post-operative complication

    10. Length of stay [Discharge]

      Time from surgery to discharge

    11. Procedure related readmissions [Day 90]

      Readmission that can be linked to the partial nephrectomy

    12. Procedure related reoperations [Day 90]

      Re-operation that can be linked to the partial nephrectomy

    13. Quality of recovery from the intervention [Baseline until Day 5 / discharge (whatever is earlier)]

      Quality of recovery questionnaire QoR-9

    14. Quality of life questionnaire, generic measure [Baseline until Day 90]

      EQ-5D 5L

    15. Quality of life questionnaire, cancer patient specific [Baseline until Day 90]

      EORTC QLQ-C30

    16. Overall survival [Day of surgery to 5 years]

      time from surgery to death from any cause

    17. Disease specific survival [Day of surgery to 5 years]

      time from surgery to death due to kidney cancer

    18. Disease free survival [Day of surgery to 5 years]

      time from surgery to first documented recurrence of renal cell carcinoma as defined by the investigator

    19. Local recurrence free survival [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.

    20. Comprehensive Complication Index [Day of surgery to 30th post operative day]

      Any complication that occurred within 30 days post surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Urology, University Hospital Düsseldorf Düsseldorf Germany 40225
    2 Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid Essen Germany 45131
    3 Department of Urology, University Hospital Freiburg Freiburg Germany 79106
    4 Universitätsklinik und Poliklinik für Urologie Halle Germany 06120
    5 Universitätsklinikum Heidelberg, Urologische Klinik Heidelberg Germany 69120
    6 Klinik für Urologie, Marien Hospital Herne Herne Germany 44625
    7 Department of Urology - Universitätsklinikum des Saarlandes Homburg Germany 66421
    8 Department of Urology, University Hospital Jena Jena Germany 07747
    9 Klinik für Urologie, Marien-Hospital Marl Marl Germany 45768
    10 Department of Urology, Klinikum rechts der Isar der Technischen Universität Munich Germany 81675
    11 Dept. of Urology, University Hospital Tübingen Tübingen Germany 72076
    12 Helios Universitätsklinkum Wuppertal - Department of Urology Wuppertal Germany 42283

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Intuitive Surgical
    ClinicalTrials.gov Identifier:
    NCT03849820
    Other Study ID Numbers:
    • OpeRa-2018
    First Posted:
    Feb 21, 2019
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Intuitive Surgical
    Robotic-assisted Surgery
    Open Surgery
    Partial Nephrectomy
    minimal invasive surgery
    RAS
    MIS
    Additional relevant MeSH terms:
    Kidney Neoplasms

    Study Results

    No Results Posted as of Jan 6, 2022