Inflammatory Response After Colorectal Cancer Surgery (CRC)

This study has been completed.
Sponsor:
Collaborator:
Hospital General Universitario Gregorio Marañon
Information provided by (Responsible Party):
Patricia Duque, M.D., Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT01427647
First received: August 29, 2011
Last updated: July 21, 2016
Last verified: July 2016
  Purpose
Laparoscopic technique and epidural anesthesia have been proposed to improve postoperative outcome following colorectal cancer surgery. The investigators hypothesize that the inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared to traditional open surgery under general anesthesia.

Condition Intervention
Colorectal Cancer
Procedure: Laparoscopic technique and thoracic epidural anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inflammatory Response Following Colorectal Cancer Surgery Depends on the Type of Anesthesia and Surgery

Resource links provided by NLM:


Further study details as provided by Universidad Complutense de Madrid:

Primary Outcome Measures:
  • Plasma levels of several cytokines after colorectal cancer surgery [ Time Frame: within the first two days after surgery ] [ Designated as safety issue: No ]
    We have measured and compared perioperative plasma levels of interleukin-1, interleukin-2, interleukin-6,monocyte chemotactic protein-1, interleukin-8, nitric oxide, C-reactive protein and procalcitonin in our three-group sample.


Secondary Outcome Measures:
  • Incidence of adverse clinical outcomes between groups [ Time Frame: within 30 days after surgery ] [ Designated as safety issue: Yes ]
    We have analyzed if there is any significant difference on respiratory, cardiac, renal or infectious postoperative complications between groups


Enrollment: 63
Study Start Date: June 2007
Study Completion Date: February 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control group
Control group: open surgery under general anesthesia
Procedure: Laparoscopic technique and thoracic epidural anesthesia
We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques
Active Comparator: Epidural group
Epidural group: Open surgery under thoracic epidural anesthesia
Procedure: Laparoscopic technique and thoracic epidural anesthesia
We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques
Active Comparator: Laparoscopic group
Laparoscopic group: Laparoscopic surgery under general anesthesia
Procedure: Laparoscopic technique and thoracic epidural anesthesia
We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques

Detailed Description:

Patients scheduled for open colorectal cancer surgery were randomly allocated to receive general anesthesia (CON group, n=22) or general anesthesia with thoracic epidural anesthesia (EPI group, n=21). Patients undergoing laparoscopic surgery (LAP group, n=20) composed the third arm of the study. Measurement of perioperative changes in several hormones and cytokines were blinded to group assignment.

Primary outcome: Compare simultaneously two types of surgical and anesthesia techniques for colorectal cancer surgery and measure to what extent the stress response is lessened.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for colorectal cancer surgery

Exclusion Criteria:

  • Emergent surgery
  • Intestinal obstruction
  • Contraindication for epidural catheter placement
  • Concomitant autoimmune disease
  • Concomitant infectious disease
  • Recent corticosteroids or anti-inflammatory medications
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01427647

Locations
Spain
Gregorio Marañon Hospital
Madrid, Spain, 28007
Sponsors and Collaborators
Universidad Complutense de Madrid
Hospital General Universitario Gregorio Marañon
Investigators
Principal Investigator: Patricia Duque, MD Gregorio Marañon Hospital
  More Information

Responsible Party: Patricia Duque, M.D., Anesthesiologist staff, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT01427647     History of Changes
Other Study ID Numbers: Complutense University 1 
Study First Received: August 29, 2011
Last Updated: July 21, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Universidad Complutense de Madrid:
Laparoscopy
Anesthesia, Epidural

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016