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

Sponsor

University of Southern Denmark (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04687384

Collaborator

Region of Southern Denmark (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms Colon Cancer Systemic Inflammatory Response Syndrome Inflammation Robotic Surgical Procedures Laparoscopy Peritoneal Inflammation	Procedure: Robotic-assisted colectomy Procedure: Conventional laparoscopic colectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Robotic-assisted surgery

Patients undergoing robotic-assisted colectomy for colonic neoplasm

Procedure: Robotic-assisted colectomy

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

Active Comparator: Laparoscopy

Patients undergoing conventional laparoscopic colectomy for colonic neoplasm

Procedure: Conventional laparoscopic colectomy

Conventional laparoscopic colectomy

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
Conversion rate to open surgery [1 day]
Number of conversions to open surgery
Length of surgery (total anesthesia time) [1 day]
Measured in minutes
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

Other Outcome Measures

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
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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