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

University of Southern Denmark1 site in 1 country50 target enrollmentAugust 1, 2021

ConditionsColonic Neoplasms Colon Cancer Systemic Inflammatory Response Syndrome Inflammation Robotic Surgical Procedures Laparoscopy Peritoneal Inflammation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colonic Neoplasms
Sponsor: University of Southern Denmark
Enrollment: 50
Locations: 1
Primary Endpoint: Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2021

End Date

September 1, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Southern Denmark

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

Lymph node yield(14 days)
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)
Length of surgery (total surgical time)(1 day)
Length of hospital stay(14 days)
Postoperative pain(Baseline and postoperative (day 1-3 and 14))
Time to first flatus(Postoperative (day 1-3))
Time to first bowel movement(Postoperative (day 1-3))