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Inflammatory Response After Colorectal Cancer Surgery (CRC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01427647
First Posted: September 1, 2011
Last Update Posted: July 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hospital General Universitario Gregorio Marañon
Information provided by (Responsible Party):
Patricia Duque, M.D., Universidad Complutense de Madrid
  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
Intervention Model: Factorial Assignment
Masking: Double (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 Patricia Duque, M.D., 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 ]
    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 ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 29, 2011
First Posted: September 1, 2011
Last Update Posted: July 22, 2016
Last Verified: July 2016

Keywords provided by Patricia Duque, M.D., 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