Robotic-assisted vs. Open Partial Nephrectomy (ROBOCOP)

September 2, 2021 updated by: Karl-Friedrich Kowalewski, Universitätsmedizin Mannheim

ROBOtic-assisted Versus Conventional Open Partial Nephrectomy: a Single-center, Open-label, Randomized Controlled Feasibility Trial

ROBOCOP is an open-label, randomized controlled feasibility trial comparing robotic-assisted and open partial nephrectomy in preparation for a confirmative phase III randomized controlled trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Surgical excision is the gold standard for the treatment for localized kidney cancer. An organ-preserving procedure should be carried out whenever possible in order to maintain kidney function. Partial nephrectomy can be performed through the conventional open technique as well as through a robotic-assisted approach. Although both methods belong to the standard care, there is still no published data from randomized controlled trials in the scientific literature comparing them. The ROBOCOP-trial is designed as a single-center comparison of the two surgical approaches in preparation for a phase III study. 50 patients are to be included in the trial within a period of 15 months. The primary endpoint is feasibility of patient recruitment. In addition, potential primary outcomes for a confirmative trial such as perioperative complications, quality of life, inflammatory response, survival and ergonomic aspects for the operating surgeons will be investigated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68167
        • Recruiting
        • Department of Urology, University Medical Center Mannheim, University of Heidelberg
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maximilian C. Kriegmair, M.D.
        • Principal Investigator:
          • Karl-Friedrich Kowalewski, M.D.
        • Sub-Investigator:
          • Honeck Patrick, M.D.
        • Sub-Investigator:
          • Nuhn Philipp, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • scheduled for elective partial nephrectomy for renal neoplasms
  • Patient must be at least 18 years old and capable to consent
  • abdominal MRI or CT scan
  • curative-intent surgery
  • robotic-assisted and open approach for surgery are both feasible
  • ability of patient to understand the goal, consequences and alternatives of participation in the trial
  • written informed consent

Exclusion Criteria:

  • patients with solitary kidney
  • multiple kidney tumors
  • emergency intervention, for example because of bleeding or perforation
  • 2nd malignancy that will make PN needless, this does not include secondary malignancies which are under curative treatment or cases in which death from RCC is more likely
  • patient belongs to a vulnerable patient group
  • simultaneous 2nd surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Robotic-assisted partial nephrectomy
Partial nephrectomy will be performed using a robotic-assisted laparoscopic approach.
Procedure: Partial nephrectomy
Partial nephrectomy for localized kidney cancer as curative treatment.
Other Names:
  • nephron-sparing surgery
Active Comparator: Open partial nephrectomy
Partial nephrectomy will be performed using an open retroperitoneal approach.
Procedure: Partial nephrectomy
Partial nephrectomy for localized kidney cancer as curative treatment.
Other Names:
  • nephron-sparing surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 15 months
Proportion of randomized patients in relation to the eligible ones.
15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perioperative complications
Time Frame: throughout patient´s hospital stay, on average 6 days
Measured with 1) the comprehensive complication index (CCI), on a scale from 0 (no complications) to 100 (death) and 2) the Clavien-Dindo classification, which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death
throughout patient´s hospital stay, on average 6 days
Postoperative complications
Time Frame: 90 days
Measured with 1) the comprehensive complication index (CCI), on a scale from 0 (no complications) to 100 (death) and 2) the Clavien-Dindo classification, which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death
90 days
Self-reported generic health status
Time Frame: 90 days
Patient-reported generic health status using EQ-5D-5L(EuroQol-5D-5L) questionnaire (the scale ranges from 0 to 100, with 100 representing the highest health status)
90 days
Self-reported quality of life assessment of cancer patients
Time Frame: 90 days
Cancer patients will be reporting their quality of life making use of the questionnaire QLQ-C30 (Quality of Life Questionnaire C30) (range 0-100, high scores represent a better quality of life)
90 days
Self-reported quality of life in patients with kidney disease
Time Frame: 90 days
Patients will assess the influence of their kidney disease on everyday activities, work status, social interactions, mental and physical health making use of KDQOL-SF (Kidney Disease Quality of Life Short Form), ranging from 0 ("worst possible health") to 10 ("best possible health")
90 days
Self-assessment of depression in patients ≥ 65 years old
Time Frame: 90 days
Elderly patients (≥ 65 years old) will report their depression symptoms filling GDS (Geriatric Depression Scale) questionnaire, ranging from 0 to 30, with 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".
90 days
Self-evaluation of cancer disease´s influence on elderly patients´ life
Time Frame: 90 days
Elderly patients (≥ 65 years old) will evaluate the influence of their cancer disease on their life (activities of daily living, cognition, mood, nutritional status, mobility, polypharmacy and social support), on a scale ranging from 0 to 17, 17 indicating the best outcome possible on quality of life.
90 days
Self-assessment of comorbidity in elderly patients
Time Frame: 90 days
Elderly patients (≥ 65 years old) will make use of SCQ (Self-Administered Comorbidity Questionnaire) to assess common comorbidities; a higher score indicates higher comorbidities (range 0-39)
90 days
Postoperative self-reported quality of life
Time Frame: 90 days
Participants will evaluate their postoperative quality of life on a 0-100 scale, higher scores indicating a better quality of life and return to daily life activities.
90 days
Kidney function - creatinine
Time Frame: 90 days
postoperative change in kidney function - creatinine (measured in mg/dL)
90 days
Kidney function - GFR
Time Frame: 90 days
postoperative change in kidney function - glomerular filtration rate (measured in mL/min)
90 days
Length of hospital stay
Time Frame: throughout patient´s hospital stay, on average 6 days
Total time of hospital stay
throughout patient´s hospital stay, on average 6 days
Operative time
Time Frame: Immediately after surgery
Surgery duration
Immediately after surgery
Inflammatory response - leucocytes
Time Frame: throughout patient´s hospital stay, on average 6 days
postoperative course of inflammatory parameters (leucocytes, unit of measure: white cells x10^9/L)
throughout patient´s hospital stay, on average 6 days
Inflammatory response - C-reactive protein
Time Frame: throughout patient´s hospital stay, on average 6 days
postoperative course of inflammatory parameters (c-reactive protein, measured in mg/L)
throughout patient´s hospital stay, on average 6 days
Inflammatory response
Time Frame: throughout patient´s hospital stay, on average 6 days
postoperative course of inflammatory parameters (IL-6, TNF-α, IL-1β, VEGF, measured in ng/L)
throughout patient´s hospital stay, on average 6 days
Surgical ergonomics
Time Frame: Immediately after surgery
Surgeons will be asked to evaluate localized muscle pain on a scale from 0 to 10, 10 indicating extreme discomfort
Immediately after surgery
Surgical ergonomics
Time Frame: During surgery
Surgeons will be asked to fill NASA TLX questionnaire (NASA Task Load Index). Range: 0-100, high scores indicate a high task load
During surgery
Resection status
Time Frame: up to 5 days
Rate of R0/R1 status in each arm
up to 5 days
Use of analgesia
Time Frame: throughout patient´s hospital stay, on average 6 days
Need for pain medications
throughout patient´s hospital stay, on average 6 days
Trifecta outcomes of partial nephrectomy
Time Frame: 90 days
Trifecta is defined as no major complication, R0-resection status and ischemia time of less than 25 minutes
90 days
Blood loss
Time Frame: Immediately after surgery
Blood loss during surgery
Immediately after surgery
Conversion to open surgery
Time Frame: Immediately after surgery
Rate of conversion to open surgery
Immediately after surgery
Conversion to radical nephrectomy
Time Frame: Immediately after surgery
Rate of conversion to radical nephrectomy
Immediately after surgery
Case cost
Time Frame: 90 days
DRG-related case costs per arm
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsmedizin Mannheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dietmar Hopp Stiftung
Institute of Medical Biometry and Informatics, University of Heidelberg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maximilian C. Kriegmair, M.D., Department of Urology, University Medical Center Mannheim, University of Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-542N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient information might be shared after signing a data sharing agreement and IRB approval

IPD Sharing Time Frame

After completion of the study (anticipated March 2021)

IPD Sharing Supporting Information Type

  • Study Protocol
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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