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

NCT04687384 | Unknown

• 1 other identifier: 75709
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

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

  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)

  30 days

• Differences in intraoperative blood loss

  1 day

• Conversion rate to open surgery

  1 day

• Length of surgery (total anesthesia time)

  1 day

Other Outcomes (6)

• Levels of peritoneal inflammatory response in peritoneal fluid

  Postoperative (day 1-3)

• Patient reported health related quality of recovery (QoR-15)

  Baseline and postoperative (day 1-3 and 14)

• Mortality

  30 days

Study Arms (2)

Robotic-assisted surgery

EXPERIMENTAL

Patients undergoing robotic-assisted colectomy for colonic neoplasm

Procedure: Robotic-assisted colectomy

Laparoscopy

ACTIVE COMPARATOR

Patients undergoing conventional laparoscopic colectomy for colonic neoplasm

Procedure: Conventional laparoscopic colectomy

Interventions

Robotic-assisted colectomy PROCEDURE

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

Robotic-assisted surgery

Conventional laparoscopic colectomy PROCEDURE

Conventional laparoscopic colectomy

Laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Region of Southern Denmark: collaborator

Study Sites (1)

Hospital of Southern Denmark

Aabenraa, Denmark

Location

Related Publications (2)

• Cuk P, Tiskus M, Moller S, Lambertsen KL, Backer Mogensen C, Festersen Nielsen M, Helligso P, Gogenur I, Bremholm Ellebaek M. Surgical stress response in robot-assisted versus laparoscopic surgery for colon cancer (SIRIRALS): randomized clinical trial. Br J Surg. 2024 Mar 2;111(3):znae049. doi: 10.1093/bjs/znae049.

  PMID: 38445434 DERIVED

• 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.

  PMID: 34635066 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Systemic Inflammatory Response Syndrome; Inflammation; Peritonitis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Intraabdominal Infections; Infections; Peritoneal Diseases

Study Officials

• Pedja Cuk, MD

  Surgical Department, Hospital of Southern Jutland, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedja Cuk, MD

CONTACT

+4579970000; pedja.cuk@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 29, 2020
• Study Start: August 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)