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

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ClinicalTrials.gov Identifier: NCT04687384
Recruitment Status : Not yet recruiting
First Posted : December 29, 2020
Last Update Posted : June 16, 2021
Sponsor:
Collaborator:
Region of Southern Denmark
Information provided by (Responsible Party):
University of Southern Denmark

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Changes in levels of systemic inflammation in serum between the two groups [ Time Frame: 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

  2. Differences in number of patients with postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index (CCI) [ Time Frame: 30 days ]
    Number of complications obtained from medical records

  3. Differences in intraoperative blood loss [ Time Frame: 1 day ]
    Measured in mL

  4. Conversion rate to open surgery [ Time Frame: 1 day ]
    Number of conversions to open surgery

  5. Length of surgery (total anesthesia time) [ Time Frame: 1 day ]
    Measured in minutes

  6. Length of surgery (total surgical time) [ Time Frame: 1 day ]
    Measured in minutes

  7. Lymph node yield [ Time Frame: 14 days ]
    Pathological examination of lymph nodes

  8. Length of hospital stay [ Time Frame: 14 days ]
    Measured in days

  9. Postoperative pain [ Time Frame: Baseline and postoperative (day 1-3 and 14) ]
    Measured by VAS-scale

  10. Time to first flatus [ Time Frame: Postoperative (day 1-3) ]
    Measured in hours

  11. Time to first bowel movement [ Time Frame: Postoperative (day 1-3) ]
    Measured in hours


Other Outcome Measures:
  1. Levels of peritoneal inflammatory response in peritoneal fluid [ Time Frame: 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

  2. Patient reported health related quality of recovery (QoR-15) [ Time Frame: 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.

  3. Mortality [ Time Frame: 30 days ]
    Number of mortality obtained from medical charts

  4. Heart rate variability [ Time Frame: Postoperative (day 1-3) ]
    The heart rate will continuously recorded by ECG intra- and postoperatively

  5. Whole blood gene expression profiling [ Time Frame: Baseline and postoperative (day 1-3) ]
    Gene mRNA transcript analysis

  6. Time to local cancer recurrence or metastatic spread [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04687384


Contacts
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Contact: Pedja Cuk, MD +4579970000 pedja.cuk@rsyd.dk

Locations
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Denmark
Hospital of Southern Denmark
Aabenraa, Denmark
Contact: Pedja Cuk, MD         
Principal Investigator: Pedja Cuk, MD         
Sponsors and Collaborators
University of Southern Denmark
Region of Southern Denmark
Investigators
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Principal Investigator: Pedja Cuk, MD Surgical Department, Hospital of Southern Jutland, Denmark
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT04687384    
Other Study ID Numbers: 75709
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Southern Denmark:
Systemic inflammatory response
Colonic neoplasm
Robotic assisted surgery
Laparoscopy
Additional relevant MeSH terms:
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Peritonitis
Colonic Neoplasms
Inflammation
Systemic Inflammatory Response Syndrome
Neoplasms
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Shock
Intraabdominal Infections
Infections
Peritoneal Diseases