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

Study Overview
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Brief Summary
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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.

Official Title
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Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer (SIRIRALS-trial): a Randomized Controlled Trial

Conditions
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Colonic Neoplasms, Colon Cancer, Systemic Inflammatory Response Syndrome, Inflammation, Robotic Surgical Procedures, Laparoscopy, Peritoneal Inflammation

Intervention / Treatment
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* Procedure: Robotic-assisted colectomy
* Procedure: Conventional laparoscopic colectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic-assisted surgery<br>Patients undergoing robotic-assisted colectomy for colonic neoplasm | Procedure: Robotic-assisted colectomy<br>* Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology<br>|
| Active Comparator: Laparoscopy<br>Patients undergoing conventional laparoscopic colectomy for colonic neoplasm | Procedure: Conventional laparoscopic colectomy<br>* Conventional laparoscopic colectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline and postoperative (day 1-3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 30 days | 
| Differences in intraoperative blood loss | Measured in mL | 1 day | 
| Conversion rate to open surgery | Number of conversions to open surgery | 1 day | 
| Length of surgery (total anesthesia time) | Measured in minutes | 1 day | 
| Length of surgery (total surgical time) | Measured in minutes | 1 day | 
| Lymph node yield | Pathological examination of lymph nodes | 14 days | 
| Length of hospital stay | Measured in days | 14 days | 
| Postoperative pain | Measured by VAS-scale | Baseline and postoperative (day 1-3 and 14) | 
| Time to first flatus | Measured in hours | Postoperative (day 1-3) | 
| Time to first bowel movement | Measured in hours | Postoperative (day 1-3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic inflammatory response, Colonic neoplasm, Robotic assisted surgery, Laparoscopy