Clinical trial NCT04687384: Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer
Official title: Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer (SIRIRALS-trial): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Neoplasms
Colon Cancer
Systemic Inflammatory Response Syndrome
Inflammation
Robotic Surgical Procedures
Laparoscopy
Peritoneal Inflammation
Keywords: Systemic inflammatory response
Colonic neoplasm
Robotic assisted surgery
Laparoscopy
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
First posted: 2020-12-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups
timeFrame: Baseline and postoperative (day 1-3)
Secondary outcomes:
measure: Changes in levels of systemic inflammation in serum between the two groups
timeFrame: Baseline and postoperative (day 1-3)
measure: Differences in number of patients with postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index (CCI)
timeFrame: 30 days
measure: Differences in intraoperative blood loss
timeFrame: 1 day
measure: Conversion rate to open surgery
timeFrame: 1 day
measure: Length of surgery (total anesthesia time)
timeFrame: 1 day
measure: Length of surgery (total surgical time)
timeFrame: 1 day
measure: Lymph node yield
timeFrame: 14 days
measure: Length of hospital stay
timeFrame: 14 days
measure: Postoperative pain
timeFrame: Baseline and postoperative (day 1-3 and 14)
measure: Time to first flatus
timeFrame: Postoperative (day 1-3)
measure: Time to first bowel movement
timeFrame: Postoperative (day 1-3)
Other outcomes:
measure: Levels of peritoneal inflammatory response in peritoneal fluid
timeFrame: Postoperative (day 1-3)
measure: Patient reported health related quality of recovery (QoR-15)
timeFrame: Baseline and postoperative (day 1-3 and 14)
measure: Mortality
timeFrame: 30 days
measure: Heart rate variability
timeFrame: Postoperative (day 1-3)
measure: Whole blood gene expression profiling
timeFrame: Baseline and postoperative (day 1-3)
measure: Time to local cancer recurrence or metastatic spread
timeFrame: 3 years postoperatively
Locations:
city: Aabenraa
country: Denmark
facility: Hospital of Southern Denmark
Study officials:
affiliation: Surgical Department, Hospital of Southern Jutland, Denmark
name: Pedja Cuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cuk P, Pedersen AK, Lambertsen KL, Mogensen CB, Nielsen MF, Helligso P, Gogenur I, Ellebaek MB. Systemic inflammatory response in robot-assisted and laparoscopic surgery for colon cancer (SIRIRALS): study protocol of a randomized controlled trial. BMC Surg. 2021 Oct 11;21(1):363. doi: 10.1186/s12893-021-01355-4.