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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Partial nephrectomy for localized kidney cancer as curative treatment.
Department of Urology, University Medical Center Mannheim, University of Heidelberg
Mannheim, Baden-Wurttemberg, Germany
RECRUITINGRecruitment rate
Proportion of randomized patients in relation to the eligible ones.
Time frame: 15 months
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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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")
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Time frame: 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".
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 90 days
Kidney function - creatinine
postoperative change in kidney function - creatinine (measured in mg/dL)
Time frame: 90 days
Kidney function - GFR
postoperative change in kidney function - glomerular filtration rate (measured in mL/min)
Time frame: 90 days
Length of hospital stay
Total time of hospital stay
Time frame: throughout patient´s hospital stay, on average 6 days
Operative time
Surgery duration
Time frame: Immediately after surgery
Inflammatory response - leucocytes
postoperative course of inflammatory parameters (leucocytes, unit of measure: white cells x10\^9/L)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: During surgery
Resection status
Rate of R0/R1 status in each arm
Time frame: up to 5 days
Use of analgesia
Need for pain medications
Time frame: 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
Time frame: 90 days
Blood loss
Blood loss during surgery
Time frame: Immediately after surgery
Conversion to open surgery
Rate of conversion to open surgery
Time frame: Immediately after surgery
Conversion to radical nephrectomy
Rate of conversion to radical nephrectomy
Time frame: Immediately after surgery
Case cost
DRG-related case costs per arm
Time frame: 90 days