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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04687384
• Other study ID #: 75709
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: June 2021
• Source: University of Southern Denmark
• Contact: Pedja Cuk, MD
• Phone: +4579970000
• Email: pedja.cuk[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Inflammation
• Laparoscopy
• Peritoneal Inflammation
• Peritonitis
• Robotic Surgical Procedures
• Systemic Inflammatory Response Syndrome

Intervention

Procedure:
• Robotic-assisted colectomy
Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology
• Conventional laparoscopic colectomy
Conventional laparoscopic colectomy

Locations

Country	Name	City	State
Denmark	Hospital of Southern Denmark	Aabenraa

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Levels of peritoneal inflammatory response in peritoneal fluid	Levels of cytokines are expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-?, IL-1a, IL-1ß, 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-1a, MIP-1ß, TARC, TNF-a, TNF-ß, VEGF-A as well as IL-1RA and CRP. All cytokines are measured in pg/mL, CRP measured in mg/L	Postoperative (day 1-3)
Other	Patient reported health related quality of recovery (QoR-15)	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.	Baseline and postoperative (day 1-3 and 14)
Other	Mortality	Number of mortality obtained from medical charts	30 days
Other	Heart rate variability	The heart rate will continuously recorded by ECG intra- and postoperatively	Postoperative (day 1-3)
Other	Whole blood gene expression profiling	Gene mRNA transcript analysis	Baseline and postoperative (day 1-3)
Other	Time to local cancer recurrence or metastatic spread	The two surgical methods will be compared in order to obtain any differences in the local or metastatic cancer recurrence	3 years postoperatively
Primary	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	Changes in levels of systemic inflammation in serum between the two groups	The cytokine levels are expressed by: Eotaxin, Eotaxin-3, GM-CSF, IFN-?, IL-1a, IL-1ß, 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-1a, MIP-1ß, TARC, TNF-a, TNF-ß, VEGF-A and IL-1RA. All cytokines are measured in pg/mL	Baseline and postoperative (day 1-3)
Secondary	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	30 days
Secondary	Differences in intraoperative blood loss	Measured in mL	1 day
Secondary	Conversion rate to open surgery	Number of conversions to open surgery	1 day
Secondary	Length of surgery (total anesthesia time)	Measured in minutes	1 day
Secondary	Length of surgery (total surgical time)	Measured in minutes	1 day
Secondary	Lymph node yield	Pathological examination of lymph nodes	14 days
Secondary	Length of hospital stay	Measured in days	14 days
Secondary	Postoperative pain	Measured by VAS-scale	Baseline and postoperative (day 1-3 and 14)
Secondary	Time to first flatus	Measured in hours	Postoperative (day 1-3)
Secondary	Time to first bowel movement	Measured in hours	Postoperative (day 1-3)