Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT04687384
NCT04687384UnknownNot Applicable

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 enrollmentStarted: August 1, 2021Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
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
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Robotic-assisted surgery

Experimental

Patients undergoing robotic-assisted colectomy for colonic neoplasm

Intervention: Robotic-assisted colectomy (Procedure)

Laparoscopy

Active Comparator

Patients undergoing conventional laparoscopic colectomy for colonic neoplasm

Intervention: Conventional laparoscopic colectomy (Procedure)

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)
  • Postoperative pain(Baseline and postoperative (day 1-3 and 14))
  • 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)
  • Time to first flatus(Postoperative (day 1-3))
  • Time to first bowel movement(Postoperative (day 1-3))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Inflammation After Laparoscopic Robot-assisted Surgery for Locally Advanced Rectal CancerLocally Advanced Rectal CancerAbdominoperineal Resection
NCT04324567Oslo University Hospital55
Recruiting
Not Applicable
Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial CancerEndometrial CancerObesity, MorbidGynecologic CancerEndometrial NeoplasmsGynecologic Disease
NCT05974995Fondazione Policlinico Universitario Agostino Gemelli IRCCS566
Completed
Not Applicable
The Influences of Long Periods of Pneumoperitoneum and Head up Position on the Variation of Heart-rate Corrected QT Interval During Robotic-assisted Laparoscopic Gastrectomy - Observational StudyStomach Cancer
NCT02604979Yonsei University30
Completed
Not Applicable
The Effect of Pneumoperitoneum (Raised Pressure in the Peritoneal Cavity) During Robotic Kidney/Prostate Cancer Surgery.KidneyPneumoperitoneumAcute Kidney Injury
NCT04755452Aalborg University Hospital100
Unknown
Not Applicable
Surgical Stress and Colorectal SurgerySurgical Stress and Immune Function
NCT02871960Federico II University170