Colon Cancer, Colonic Neoplasms, Inflammation, Laparoscopy, Peritoneal Inflammation, Robotic Surgical Procedures, Systemic Inflammatory Response Syndrome
Conditions
Keywords
Systemic inflammatory response, Colonic neoplasm, Robotic assisted surgery, Laparoscopy
Brief summary
The current hypothesis is that robotic-assisted surgery results in a reduced systemic and peritoneal inflammatory response (SIRS) compared to laparoscopic surgery in the treatment of colon cancer. The purpose is to evaluate differences in the peritoneal and systemic inflammatory response in robot-assisted and laparoscopic surgery of patients undergoing resection for colon cancer in a randomized, blinded controlled trial.
Interventions
PROCEDURERobotic-assisted colectomy
Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology
PROCEDUREConventional laparoscopic colectomy
Conventional laparoscopic colectomy
Sponsors
Region of Southern Denmark
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective robotic-assisted or laparoscopic surgery for right-sided, left-sided and sigmoid colon cancer * Aged ≥ 18 * ASA-score ≤ 3 * Tumor-stage (Tx-T4a) * Endoscopic suspected colon cancer * Histological verified adenocarcinoma, signet ring cell carcinoma, undifferentiated cancer, medullary carcinoma, or another malignant tumor type originating from colon * Patients must give informed written consent * Patients must be able to understand Danish language
Exclusion criteria
* Carcinoma of the transverse colon or synchronous colorectal cancer * Previous history of colon cancer * Previous open major abdominal surgery with exception of open appendectomy and cholecystectomy. * Metastatic disease * Pregnancy * 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 that requiring ingestion of systemic immunomodulatory drugs (DMARD - disease modifying anti-rheumatic drugs), corticosteroids and biologic disease-modifying anti-rheumatic drugs. * Daily consumption of NSAID drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups | Baseline and postoperative (day 1-3) | CRP (mg/L), IL-6 (pg/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate to open surgery | 1 day | Number of conversions to open surgery |
| Length of surgery (total surgical time) | 1 day | Measured in minutes |
| Lymph node yield | 14 days | Pathological examination of lymph nodes |
| Length of hospital stay | 14 days | Measured in days |
| Postoperative pain | Baseline and postoperative (day 1-3 and 14) | Measured by VAS-scale |
| Time to first flatus | Postoperative (day 1-3) | Measured in hours |
| Time to first bowel movement | Postoperative (day 1-3) | Measured in hours |
| Changes in levels of systemic inflammation in serum between the two groups | Baseline and postoperative (day 1-3) | The cytokine levels are expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-7, IL-8, IL-8 (HA), IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A and IL-1RA. All cytokines are measured in pg/mL |
| Differences in number of patients with postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index (CCI) | 30 days | Number of complications obtained from medical records |
| Differences in intraoperative blood loss | 1 day | Measured in mL |
| Length of surgery (total anesthesia time) | 1 day | Measured in minutes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | Number of mortality obtained from medical charts |
| Heart rate variability | Postoperative (day 1-3) | The heart rate will continuously recorded by ECG intra- and postoperatively |
| Whole blood gene expression profiling | Baseline and postoperative (day 1-3) | Gene mRNA transcript analysis |
| Time to local cancer recurrence or metastatic spread | 3 years postoperatively | The two surgical methods will be compared in order to obtain any differences in the local or metastatic cancer recurrence |
| Patient reported health related quality of recovery (QoR-15) | Baseline and postoperative (day 1-3 and 14) | Recovery is measured according to quality of recovery 15 score (QoR-15). The score ranges from 0-150. A high score indicates a good recovery. |
| Levels of peritoneal inflammatory response in peritoneal fluid | Postoperative (day 1-3) | Levels of cytokines are 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-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, TARC, TNF-α, TNF-β, VEGF-A as well as IL-1RA and CRP. All cytokines are measured in pg/mL, CRP measured in mg/L |
Countries
Denmark
Contacts
Primary ContactPedja Cuk, MD
Outcome results
None listed