Background
Methods/design
Study design
Inclusion criteria
-
Elective robot-assisted or laparoscopic surgery for right-sided, left-sided and sigmoid colon cancer.
-
Age ≥ 18.
-
ASA-score ≤ 3.
-
Tumor-stage (T1–T4a).
-
Endoscopic suspected colon cancer.
-
Histologically verified adenocarcinoma, signet ring cell carcinoma, undifferentiated cancer, medullary carcinoma or another malignant tumour type originating from the colon.
-
Patients must give written informed consent.
-
Patients must be able to understand Danish.
Exclusion criteria
-
Carcinoma of the transverse colon or synchronous colorectal cancer.
-
Previous history of any colon resection.
-
Previous open major abdominal surgery except for open appendectomy and cholecystectomy.
-
Pregnancy.
-
Metastatic disease.
-
History of psychiatric or addictive disorder that would prevent the patient from participating in the trial.
-
Emergency colon surgery.
-
Co-existing inflammatory bowel disease.
-
Co-existing immunological disease requiring ingestion of systemic immunomodulatory drugs (DMARD—disease-modifying anti-rheumatic drugs) - uploaded as Additional file 1, corticosteroids and/or biologic disease-modifying anti-rheumatic drugs.
-
Daily consumption of NSAID drugs.
Interventions
Surgical procedures
Right-sided colectomy
Left-sided colectomy
Sigmoid colectomy
Peritoneal microdialysis
Postoperative management
Anesthesia and postoperative analgesic management
Preoperative medication
Maintenance of general anaesthesia
-
Propofol (1–3 mg/kg) initially followed by a continuous dose of 5 mg/kg/hour.
-
Sufentanil (0.5 μg/kg) initially followed by a continuous dose of 1,5 μg/kg.
-
Rocuronium (0.6 mg/kg) initially followed by a continuous dose of 0.3–0.6 mg/kg.
-
Oxycodone (0.1 mg/kg) 30 minutes before the cessation of the procedure.
-
Rocuronium if train-of-four is 0–1.
-
Remifentanil (0.15 μg/kg).
Postoperative management
-
Paracetamol 1 g × 4.
-
Oxycontin 5–10 mg × 2.
-
Oxynorm 5–10 mg × 2 (pro necessaire).
-
Ondansetron 4 mg (pro necessaire).
Outcomes
-
Levels of systemic inflammatory response expressed by serum C-reactive protein (CRP) and interleukin 6 (IL-6) measured postoperatively day one to day threeSecondary endpoints
-
Levels of systemic inflammation in serum expressed by: Eotaxin, Eotaxin-3, granulocyte–macrophage colony-stimulating factor (GM-CSF), interferon-gamma (IFN-γ), interleukin 1 alpha (IL-1α), interleukin 1 beta (IL-1β), interleukin 2 (IL-2), interleukin 4 (IL-4), interleukin 5 (IL-5), interleukin 7 (IL-7), interleukin 8 (IL-8), interleukin 10 (IL-10), interleukin 12 (IL-12), interleukin 23 (IL-23), interleukin 13 (IL-13), interleukin 15 (IL-15), interleukin 16 (IL-16), interleukin 17a (IL-17A), interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), monocyte chemoattractant protein 4 (MCP-4), macrophage derived chemokine (MDC), macrophage inflammatory protein 1 alpha (MIP-1α), macrophage inflammatory protein 1 beta (MIP-1β), thymus and activation regulated chemokine (TARC), tumor necrosis factor alpha (TNF-α), tumor necrosis factor alpha (TNF-β) lymphotoxin alpha (LT-α), vascular endothelial growth factor A (VEGF-A) and interleukin 1 receptor antagonist (IL-1RA) measured on the first three postoperative days.
-
Postoperative dynamic pain registration (visual analog scale (VAS)) at rest twice daily (morning and evening) and registration of opioid consumption in medical charts.
-
Intraoperative blood loss (mL).
-
Conversion rate to open surgery.
-
Total surgical duration (minutes).
-
Total anaesthesia duration (minutes).
-
Lymph node yield.
-
Length of hospital stay (hours/days).
-
Time to passage of flatus (hours).
-
Time to passage of stool (hours/days).
Exploratory endpoints
-
Levels of peritoneal inflammatory response in peritoneal fluid expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-10, IL-12, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF, LT-α, VEGF-A, as well as IL-1RA and CRP measured on the first three postoperative days.
-
Patient-reported health-related quality of recovery-15 (QoR-15) [29].
-
30 days mortality rate.
-
Heart rate variability.
-
Gene transcript (mRNA) analysis.
-
Comparison of the systemic and peritoneal inflammatory response in relation to the risk of cancer recurrence 3 years postoperatively.
Participant timeline, data collection and follow-up
Sample size
Recruitment, randomization and blinding
-
Age and sex
-
Confirmation that inclusion and exclusion criteria are met
-
Confirmation of informed consent
-
Planned date of operation
-
Type of operation