ROBOCOP: Robotic-assisted vs. Open Partial Nephrectomy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Recruitment rate [15 months]
Proportion of randomized patients in relation to the eligible ones.
Secondary Outcome Measures
- Perioperative complications [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
- Postoperative complications [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
- Self-reported generic health status [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)
- Self-reported quality of life assessment of cancer patients [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)
- Self-reported quality of life in patients with kidney disease [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")
- Self-assessment of depression in patients ≥ 65 years old [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".
- Self-evaluation of cancer disease´s influence on elderly patients´ life [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.
- Self-assessment of comorbidity in elderly patients [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)
- Postoperative self-reported quality of life [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.
- Kidney function - creatinine [90 days]
postoperative change in kidney function - creatinine (measured in mg/dL)
- Kidney function - GFR [90 days]
postoperative change in kidney function - glomerular filtration rate (measured in mL/min)
- Length of hospital stay [throughout patient´s hospital stay, on average 6 days]
Total time of hospital stay
- Operative time [Immediately after surgery]
Surgery duration
- Inflammatory response - leucocytes [throughout patient´s hospital stay, on average 6 days]
postoperative course of inflammatory parameters (leucocytes, unit of measure: white cells x10^9/L)
- Inflammatory response - C-reactive protein [throughout patient´s hospital stay, on average 6 days]
postoperative course of inflammatory parameters (c-reactive protein, measured in mg/L)
- Inflammatory response [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)
- Surgical ergonomics [Immediately after surgery]
Surgeons will be asked to evaluate localized muscle pain on a scale from 0 to 10, 10 indicating extreme discomfort
- Surgical ergonomics [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
- Resection status [up to 5 days]
Rate of R0/R1 status in each arm
- Use of analgesia [throughout patient´s hospital stay, on average 6 days]
Need for pain medications
- Trifecta outcomes of partial nephrectomy [90 days]
Trifecta is defined as no major complication, R0-resection status and ischemia time of less than 25 minutes
- Blood loss [Immediately after surgery]
Blood loss during surgery
- Conversion to open surgery [Immediately after surgery]
Rate of conversion to open surgery
- Conversion to radical nephrectomy [Immediately after surgery]
Rate of conversion to radical nephrectomy
- Case cost [90 days]
DRG-related case costs per arm
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Urology, University Medical Center Mannheim, University of Heidelberg | Mannheim | Baden-Württemberg | Germany | 68167 |
Sponsors and Collaborators
- Universitätsmedizin Mannheim
- Institute of Medical Biometry and Informatics, University of Heidelberg
- Dietmar Hopp Stiftung
Investigators
- Study Director: Maximilian C. Kriegmair, M.D., Department of Urology, University Medical Center Mannheim, University of Heidelberg
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-542N