Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer

University of Southern Denmark50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Colonic Neoplasms Colon Cancer Systemic Inflammatory Response Syndrome Inflammation Robotic Surgical Procedures

Interventions

Robotic-assisted colectomyPROCEDURE

Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology

Conventional laparoscopic colectomyPROCEDURE

Conventional laparoscopic colectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups

CRP (mg/L), IL-6 (pg/mL)

Time frame: Baseline and postoperative (day 1-3)

Secondary Outcomes

Changes in levels of systemic inflammation in serum between the two groups

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

Time frame: Baseline and postoperative (day 1-3)

Differences in number of patients with postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index (CCI)

Number of complications obtained from medical records

Time frame: 30 days

Differences in intraoperative blood loss

Measured in mL

Time frame: 1 day

Conversion rate to open surgery

Number of conversions to open surgery

Time frame: 1 day

Length of surgery (total anesthesia time)

Measured in minutes

Time frame: 1 day

Length of surgery (total surgical time)

Measured in minutes

Time frame: 1 day

Lymph node yield

Pathological examination of lymph nodes

Time frame: 14 days

Length of hospital stay

Measured in days

Time frame: 14 days

Postoperative pain

Measured by VAS-scale

Time frame: Baseline and postoperative (day 1-3 and 14)

Time to first flatus

Measured in hours

Time frame: Postoperative (day 1-3)

Time to first bowel movement

Measured in hours

Time frame: Postoperative (day 1-3)

Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts