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Open vs Robotic Assisted Partial Nephrectomy (OpeRa)

Primary Purpose

Renal Cancer

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Robotic-assisted partial nephrectomy
Open partial nephrectomy
Sponsored by
Intuitive Surgical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cancer focused on measuring Robotic-assisted Surgery, Open Surgery, Partial Nephrectomy, minimal invasive surgery, RAS, MIS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Urology, University Hospital Düsseldorf
  • Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid
  • Department of Urology, University Hospital Freiburg
  • Universitätsklinik und Poliklinik für Urologie
  • Universitätsklinikum Heidelberg, Urologische Klinik
  • Klinik für Urologie, Marien Hospital Herne
  • Department of Urology - Universitätsklinikum des Saarlandes
  • Department of Urology, University Hospital Jena
  • Klinik für Urologie, Marien-Hospital Marl
  • Department of Urology, Klinikum rechts der Isar der Technischen Universität
  • Dept. of Urology, University Hospital Tübingen
  • Helios Universitätsklinkum Wuppertal - Department of Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Robotic-assisted partial nephrectomy

Open partial nephrectomy

Arm Description

da Vinci surgical robotic assisted partial nephrectomy

Open partial nephrectomy surgery

Outcomes

Primary Outcome Measures

30 day complications
Any complication that occurred within 30 days post surgery

Secondary Outcome Measures

Operative time
Timing of surgical steps in the OR
Ischemia time
Period in which the kidney has no blood supply
Surgical radicality conversions
Conversion from robotic to open, partial to radical
Intraoperative blood loss
Volume of blood loss during the surgical procedure
Pain assessment
Assessment of pain level via the Brief Pain Inventory (BPI)
Pain Medication
Recording pain medication
Neuropathic pain
Development of neuropathic pain via the DN-4 Patient interview questions
Kidney function via the estimated glomerular filtration rate (eGRF)
Data will be gathered from routine examination, not a mandatory assessment
Post operative complications
Any Clavien-Dindo I-V post-operative complication
Length of stay
Time from surgery to discharge
Procedure related readmissions
Readmission that can be linked to the partial nephrectomy
Procedure related reoperations
Re-operation that can be linked to the partial nephrectomy
Quality of recovery from the intervention
Quality of recovery questionnaire QoR-9
Quality of life questionnaire, generic measure
EQ-5D 5L
Quality of life questionnaire, cancer patient specific
EORTC QLQ-C30
Overall survival
time from surgery to death from any cause
Disease specific survival
time from surgery to death due to kidney cancer
Disease free survival
time from surgery to first documented recurrence of renal cell carcinoma as defined by the investigator
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.
Comprehensive Complication Index
Any complication that occurred within 30 days post surgery

Full Information

First Posted
February 15, 2019
Last Updated
April 4, 2023
Sponsor
Intuitive Surgical
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1. Study Identification

Unique Protocol Identification Number
NCT03849820
Brief Title
Open vs Robotic Assisted Partial Nephrectomy
Acronym
OpeRa
Official Title
Open vs Robotic Assisted Partial Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to low enrollment the study was terminated
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
October 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuitive Surgical

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer
Keywords
Robotic-assisted Surgery, Open Surgery, Partial Nephrectomy, minimal invasive surgery, RAS, MIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic-assisted partial nephrectomy
Arm Type
Active Comparator
Arm Description
da Vinci surgical robotic assisted partial nephrectomy
Arm Title
Open partial nephrectomy
Arm Type
Active Comparator
Arm Description
Open partial nephrectomy surgery
Intervention Type
Device
Intervention Name(s)
Robotic-assisted partial nephrectomy
Other Intervention Name(s)
da Vinci, RAS, dVPN
Intervention Description
Application of the da Vinci surgical robot to assist the partial nephrectomy
Intervention Type
Other
Intervention Name(s)
Open partial nephrectomy
Other Intervention Name(s)
Open surgery
Intervention Description
Open surgery to conduct the partial nephrectomy
Primary Outcome Measure Information:
Title
30 day complications
Description
Any complication that occurred within 30 days post surgery
Time Frame
Day of surgery to 30th post operative day
Secondary Outcome Measure Information:
Title
Operative time
Description
Timing of surgical steps in the OR
Time Frame
Day of surgery
Title
Ischemia time
Description
Period in which the kidney has no blood supply
Time Frame
Day of surgery
Title
Surgical radicality conversions
Description
Conversion from robotic to open, partial to radical
Time Frame
Day of surgery
Title
Intraoperative blood loss
Description
Volume of blood loss during the surgical procedure
Time Frame
Day of surgery
Title
Pain assessment
Description
Assessment of pain level via the Brief Pain Inventory (BPI)
Time Frame
Baseline until Day 90
Title
Pain Medication
Description
Recording pain medication
Time Frame
Baseline until Day 90
Title
Neuropathic pain
Description
Development of neuropathic pain via the DN-4 Patient interview questions
Time Frame
Baseline and Day 30 and Day 90
Title
Kidney function via the estimated glomerular filtration rate (eGRF)
Description
Data will be gathered from routine examination, not a mandatory assessment
Time Frame
Baseline until Day 5 / discharge (whatever is earlier)
Title
Post operative complications
Description
Any Clavien-Dindo I-V post-operative complication
Time Frame
Day 90
Title
Length of stay
Description
Time from surgery to discharge
Time Frame
Discharge
Title
Procedure related readmissions
Description
Readmission that can be linked to the partial nephrectomy
Time Frame
Day 90
Title
Procedure related reoperations
Description
Re-operation that can be linked to the partial nephrectomy
Time Frame
Day 90
Title
Quality of recovery from the intervention
Description
Quality of recovery questionnaire QoR-9
Time Frame
Baseline until Day 5 / discharge (whatever is earlier)
Title
Quality of life questionnaire, generic measure
Description
EQ-5D 5L
Time Frame
Baseline until Day 90
Title
Quality of life questionnaire, cancer patient specific
Description
EORTC QLQ-C30
Time Frame
Baseline until Day 90
Title
Overall survival
Description
time from surgery to death from any cause
Time Frame
Day of surgery to 5 years
Title
Disease specific survival
Description
time from surgery to death due to kidney cancer
Time Frame
Day of surgery to 5 years
Title
Disease free survival
Description
time from surgery to first documented recurrence of renal cell carcinoma as defined by the investigator
Time Frame
Day of surgery to 5 years
Title
Local recurrence free survival
Description
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.
Time Frame
Day of surgery to 5 years
Title
Comprehensive Complication Index
Description
Any complication that occurred within 30 days post surgery
Time Frame
Day of surgery to 30th post operative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc O Grimm, MD, Prof
Organizational Affiliation
Department of Urology, University Hospital Jena
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnulf Stenzl, MD, Prof
Organizational Affiliation
Dept. of Urology, University Hospital Tübingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, University Hospital Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Department of Urology, Alfried Krupp Krankenhaus Rüttenscheid
City
Essen
ZIP/Postal Code
45131
Country
Germany
Facility Name
Department of Urology, University Hospital Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinik und Poliklinik für Urologie
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Heidelberg, Urologische Klinik
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinik für Urologie, Marien Hospital Herne
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Department of Urology - Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Department of Urology, University Hospital Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Klinik für Urologie, Marien-Hospital Marl
City
Marl
ZIP/Postal Code
45768
Country
Germany
Facility Name
Department of Urology, Klinikum rechts der Isar der Technischen Universität
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Dept. of Urology, University Hospital Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Helios Universitätsklinkum Wuppertal - Department of Urology
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Open vs Robotic Assisted Partial Nephrectomy

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