Robotic-assisted vs. Open Partial Nephrectomy (ROBOCOP)

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: Recruiting
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Procedure: Partial nephrectomy

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: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Karl-Friedrich Kowalewski, M.D.; Phone Number: 00496213832201; Email: karl-friedrich.kowalewski@umm.de

Study Locations

• Germany
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68167
      • Recruiting
      • Department of Urology, University Medical Center Mannheim, University of Heidelberg
      • Contact: Maximilian C. Kriegmair, M.D.; Email: maximilian.kriegmair@umm.de
      • Contact: Karl-Friedrich Kowalewski, M.D.; Email: karl-friedrich-kowalewski@umm.de
      • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Proportion of randomized patients in relation to the eligible ones.	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative complications	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	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	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	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	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	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	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	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	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	postoperative change in kidney function - creatinine (measured in mg/dL)	90 days
Kidney function - GFR	postoperative change in kidney function - glomerular filtration rate (measured in mL/min)	90 days
Length of hospital stay	Total time of hospital stay	throughout patient´s hospital stay, on average 6 days
Operative time	Surgery duration	Immediately after surgery
Inflammatory response - leucocytes	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	postoperative course of inflammatory parameters (c-reactive protein, measured in mg/L)	throughout patient´s hospital stay, on average 6 days
Inflammatory response	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	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	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	Rate of R0/R1 status in each arm	up to 5 days
Use of analgesia	Need for pain medications	throughout patient´s hospital stay, on average 6 days
Trifecta outcomes of partial nephrectomy	Trifecta is defined as no major complication, R0-resection status and ischemia time of less than 25 minutes	90 days
Blood loss	Blood loss during surgery	Immediately after surgery
Conversion to open surgery	Rate of conversion to open surgery	Immediately after surgery
Conversion to radical nephrectomy	Rate of conversion to radical nephrectomy	Immediately after surgery
Case cost	DRG-related case costs per arm	90 days

Collaborators and Investigators

• Sponsor: Universitätsmedizin Mannheim
• Collaborators: Dietmar Hopp Stiftung; Institute of Medical Biometry and Informatics, University of Heidelberg
• Investigators: Study Director: Maximilian C. Kriegmair, M.D., Department of Urology, University Medical Center Mannheim, University of Heidelberg

Publications and helpful links

General Publications

• Kowalewski KF, Sidoti Abate MA, Neuberger M, Kirchner M, Krisam R, Egen L, Haney CM, Siegel F, Michel MS, Honeck P, Nuhn P, Westhoff N, Kriegmair MC. ROBOCOP II (ROBOtic assisted versus conventional open partial nephrectomy) randomised, controlled feasibility trial: clinical trial protocol. BMJ Open. 2021 Nov 3;11(11):e052087. doi: 10.1136/bmjopen-2021-052087.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Anticipated): December 15, 2021
• Study Completion (Anticipated): March 15, 2022

Study Registration Dates

• First Submitted: August 16, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID 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