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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04687384
Other study ID # 75709
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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