Systemic and Peritoneal Inflammatory Response In Robotic-assisted And Laparoscopic Surgery for Colon Cancer
NCT ID: NCT04687384
Last Updated: 2021-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-08-01
2022-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Robotic-assisted surgery
Patients undergoing robotic-assisted colectomy for colonic neoplasm
Robotic-assisted colectomy
Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology
Laparoscopy
Patients undergoing conventional laparoscopic colectomy for colonic neoplasm
Conventional laparoscopic colectomy
Conventional laparoscopic colectomy
Interventions
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Robotic-assisted colectomy
Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology
Conventional laparoscopic colectomy
Conventional laparoscopic colectomy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Region of Southern Denmark
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Pedja Cuk, MD
Role: PRINCIPAL_INVESTIGATOR
Surgical Department, Hospital of Southern Jutland, Denmark
Locations
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Hospital of Southern Denmark
Aabenraa, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Pedja Cuk, MD
Role: primary
References
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Cuk P, Tiskus M, Moller S, Lambertsen KL, Backer Mogensen C, Festersen Nielsen M, Helligso P, Gogenur I, Bremholm Ellebaek M. Surgical stress response in robot-assisted versus laparoscopic surgery for colon cancer (SIRIRALS): randomized clinical trial. Br J Surg. 2024 Mar 2;111(3):znae049. doi: 10.1093/bjs/znae049.
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.
Other Identifiers
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75709
Identifier Type: -
Identifier Source: org_study_id
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