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

Not Applicable

• Conditions: Colonic Neoplasms; Systemic Inflammatory Response Syndrome; Robotic Surgical Procedures; Peritoneal Inflammation; Colon Cancer; Inflammation; Laparoscopy
• Interventions: Procedure: Robotic-assisted colectomy; Procedure: Conventional laparoscopic colectomy

• Registration Number: NCT04687384
• Lead Sponsor: University of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-29
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-16
• Study Start: 2021-08-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic-assisted surgery	Robotic-assisted colectomy	Patients undergoing robotic-assisted colectomy for colonic neoplasm
Laparoscopy	Conventional laparoscopic colectomy	Patients undergoing conventional laparoscopic colectomy for colonic neoplasm

Primary Outcome Measures

Name	Time	Method
Changes in levels of systemic inflammatory response expressed by CRP and IL-6 in serum between the two groups	Baseline and postoperative (day 1-3)	CRP (mg/L), IL-6 (pg/mL)

Secondary Outcome Measures

Name	Time	Method
Lymph node yield	14 days	Pathological examination of lymph nodes
Changes in levels of systemic inflammation in serum between the two groups	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
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	Number of complications obtained from medical records
Differences in intraoperative blood loss	1 day	Measured in mL
Conversion rate to open surgery	1 day	Number of conversions to open surgery
Length of surgery (total anesthesia time)	1 day	Measured in minutes
Length of surgery (total surgical time)	1 day	Measured in minutes
Length of hospital stay	14 days	Measured in days
Postoperative pain	Baseline and postoperative (day 1-3 and 14)	Measured by VAS-scale
Time to first flatus	Postoperative (day 1-3)	Measured in hours
Time to first bowel movement	Postoperative (day 1-3)	Measured in hours

Trial Locations

Locations (1)

Hospital of Southern Denmark; 🇩🇰 Aabenraa, Denmark