JOURNAL ONKOLOGIE – STUDIE

ROBOCOP Robotic-assisted vs. Open Partial Nephrectomy

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04534998

Studienbeginn:
Juni 2020

Letztes Update:
22.01.2021

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, Dietmar Hopp Stiftung,

Studienleiter

Maximilian C. Kriegmair, M.D.
Study Director
Department of Urology, University Medical Center Mannheim, University of Heidelberg

Kontakt

Karl-Friedrich Kowalewski, M.D.
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

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. 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.

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

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