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

Primary Purpose

Colonic Neoplasms, Colon Cancer, Systemic Inflammatory Response Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Robotic-assisted colectomy
Conventional laparoscopic colectomy
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colonic Neoplasms focused on measuring Systemic inflammatory response, Colonic neoplasm, Robotic assisted surgery, Laparoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital of Southern Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic-assisted surgery

Laparoscopy

Arm Description

Patients undergoing robotic-assisted colectomy for colonic neoplasm

Patients undergoing conventional laparoscopic colectomy for colonic neoplasm

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Changes in levels of systemic inflammation in serum between the two groups
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)
Number of complications obtained from medical records
Differences in intraoperative blood loss
Measured in mL
Conversion rate to open surgery
Number of conversions to open surgery
Length of surgery (total anesthesia time)
Measured in minutes
Length of surgery (total surgical time)
Measured in minutes
Lymph node yield
Pathological examination of lymph nodes
Length of hospital stay
Measured in days
Postoperative pain
Measured by VAS-scale
Time to first flatus
Measured in hours
Time to first bowel movement
Measured in hours

Full Information

First Posted
November 27, 2020
Last Updated
June 10, 2021
Sponsor
University of Southern Denmark
Collaborators
Region of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04687384
Brief Title
Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer
Official Title
Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer (SIRIRALS-trial): a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark
Collaborators
Region of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic-assisted surgery
Arm Type
Experimental
Arm Description
Patients undergoing robotic-assisted colectomy for colonic neoplasm
Arm Title
Laparoscopy
Arm Type
Active Comparator
Arm Description
Patients undergoing conventional laparoscopic colectomy for colonic neoplasm
Intervention Type
Procedure
Intervention Name(s)
Robotic-assisted colectomy
Intervention Description
Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology
Intervention Type
Procedure
Intervention Name(s)
Conventional laparoscopic colectomy
Intervention Description
Conventional laparoscopic colectomy
Primary Outcome Measure Information:
Title
Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups
Description
CRP (mg/L), IL-6 (pg/mL)
Time Frame
Baseline and postoperative (day 1-3)
Secondary Outcome Measure Information:
Title
Changes in levels of systemic inflammation in serum between the two groups
Description
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
Time Frame
Baseline and postoperative (day 1-3)
Title
Differences in number of patients with postoperative surgical and medical complications (30 days) according to Clavien-Dindo classification and Comprehensive Complication Index (CCI)
Description
Number of complications obtained from medical records
Time Frame
30 days
Title
Differences in intraoperative blood loss
Description
Measured in mL
Time Frame
1 day
Title
Conversion rate to open surgery
Description
Number of conversions to open surgery
Time Frame
1 day
Title
Length of surgery (total anesthesia time)
Description
Measured in minutes
Time Frame
1 day
Title
Length of surgery (total surgical time)
Description
Measured in minutes
Time Frame
1 day
Title
Lymph node yield
Description
Pathological examination of lymph nodes
Time Frame
14 days
Title
Length of hospital stay
Description
Measured in days
Time Frame
14 days
Title
Postoperative pain
Description
Measured by VAS-scale
Time Frame
Baseline and postoperative (day 1-3 and 14)
Title
Time to first flatus
Description
Measured in hours
Time Frame
Postoperative (day 1-3)
Title
Time to first bowel movement
Description
Measured in hours
Time Frame
Postoperative (day 1-3)
Other Pre-specified Outcome Measures:
Title
Levels of peritoneal inflammatory response in peritoneal fluid
Description
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
Time Frame
Postoperative (day 1-3)
Title
Patient reported health related quality of recovery (QoR-15)
Description
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.
Time Frame
Baseline and postoperative (day 1-3 and 14)
Title
Mortality
Description
Number of mortality obtained from medical charts
Time Frame
30 days
Title
Heart rate variability
Description
The heart rate will continuously recorded by ECG intra- and postoperatively
Time Frame
Postoperative (day 1-3)
Title
Whole blood gene expression profiling
Description
Gene mRNA transcript analysis
Time Frame
Baseline and postoperative (day 1-3)
Title
Time to local cancer recurrence or metastatic spread
Description
The two surgical methods will be compared in order to obtain any differences in the local or metastatic cancer recurrence
Time Frame
3 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedja Cuk, MD
Phone
+4579970000
Email
pedja.cuk@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedja Cuk, MD
Organizational Affiliation
Surgical Department, Hospital of Southern Jutland, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Southern Denmark
City
Aabenraa
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedja Cuk, MD
First Name & Middle Initial & Last Name & Degree
Pedja Cuk, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34635066
Citation
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.
Results Reference
derived

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

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