JOURNAL ONKOLOGIE – STUDIE
ROBOCOP Robotic-assisted vs. Open Partial Nephrectomy
Rekrutierend
NCT-Nummer:
NCT04534998
Studienbeginn:
Juni 2020
Letztes Update:
01.09.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Carcinoma, Renal Cell
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 2
Sponsor:
Universitätsmedizin Mannheim
Collaborator:
Institute of Medical Biometry and Informatics, University of Heidelberg
Studienleiter
Study Director
Department of Urology, University Medical Center Mannheim, University of Heidelberg
Kontakt
Kontakt:
Phone: 00496213832201
E-Mail: karl-friedrich.kowalewski@umm.de» Kontaktdaten anzeigen
Studienlocations (1 von 1)
Department of Urology, University Medical Center Mannheim, University of Heidelberg
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Maximilian C. Kriegmair, M.D.
E-Mail: maximilian.kriegmair@umm.de
Karl-Friedrich Kowalewski, M.D.
E-Mail: karl-friedrich-kowalewski@umm.de» Ansprechpartner anzeigen
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Maximilian C. Kriegmair, M.D.
E-Mail: maximilian.kriegmair@umm.de
Karl-Friedrich Kowalewski, M.D.
E-Mail: karl-friedrich-kowalewski@umm.de» Ansprechpartner anzeigen
Studien-Informationen
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. 48 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.
Ein-/Ausschlusskriterien
Inclusion Criteria:- scheduled for curative elective partial nephrectomy for renal neoplasms
- 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 metastatic disease
- co-morbidities which prevent robotic-assisted surgery
- prior major abdominal or retroperitoneal surgery which prevents robotic-assisted surgery
- patients with solitary kidney
- multiple tumors in at least one kidney
- no curative approach
- patient belongs to a vulnerable patient group
- simultaneous 2nd surgery
Studien-Rationale
Primary outcome:1. Recruitment rate (Time Frame - 15 months):
Proportion of randomized patients in relation to the eligible ones.
Secondary outcome:
1. 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
2. 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
3. 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)
4. 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)
5. 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")
6. 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".
7. 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.
8. 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)
9. 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.
10. Kidney function - creatinine (Time Frame - 90 days):
postoperative change in kidney function - creatinine (measured in mg/dL)
11. Kidney function - GFR (Time Frame - 90 days):
postoperative change in kidney function - glomerular filtration rate (measured in mL/min)
12. Length of hospital stay (Time Frame - throughout patient´s hospital stay, on average 6 days):
Total time of hospital stay
13. Operative time (Time Frame - Immediately after surgery):
Surgery duration
14. 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)
15. 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)
16. 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)
17. 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
18. 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
19. Resection status (Time Frame - up to 5 days):
Rate of R0/R1 status in each arm
20. Use of analgesia (Time Frame - throughout patient´s hospital stay, on average 6 days):
Need for pain medications
21. 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
22. Blood loss (Time Frame - Immediately after surgery):
Blood loss during surgery
23. Conversion to open surgery (Time Frame - Immediately after surgery):
Rate of conversion to open surgery
24. Conversion to radical nephrectomy (Time Frame - Immediately after surgery):
Rate of conversion to radical nephrectomy
25. Case cost (Time Frame - 90 days):
DRG-related case costs per arm
Studien-Arme
- Experimental: Robotic-assisted partial nephrectomy
Partial nephrectomy will be performed using a robotic-assisted laparoscopic approach. - Active Comparator: Open partial nephrectomy
Partial nephrectomy will be performed using an open retroperitoneal approach.
Geprüfte Regime
- Partial nephrectomy (nephron-sparing surgery):
Partial nephrectomy for localized kidney cancer as curative treatment.
Quelle: ClinicalTrials.gov