Inflammatory Response After Colorectal Cancer Surgery (CRC)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Laparoscopic technique and thoracic epidural anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Laparoscopy, Anesthesia, Epidural
Eligibility 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
Sites / Locations
- Gregorio Marañon Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control group
Epidural group
Laparoscopic group
Arm Description
Control group: open surgery under general anesthesia
Epidural group: Open surgery under thoracic epidural anesthesia
Laparoscopic group: Laparoscopic surgery under general anesthesia
Outcomes
Primary Outcome Measures
Plasma levels of several cytokines after colorectal cancer 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
We have analyzed if there is any significant difference on respiratory, cardiac, renal or infectious postoperative complications between groups
Full Information
NCT ID
NCT01427647
First Posted
August 29, 2011
Last Updated
July 21, 2016
Sponsor
Universidad Complutense de Madrid
Collaborators
Hospital General Universitario Gregorio Marañon
1. Study Identification
Unique Protocol Identification Number
NCT01427647
Brief Title
Inflammatory Response After Colorectal Cancer Surgery
Acronym
CRC
Official Title
Inflammatory Response Following Colorectal Cancer Surgery Depends on the Type of Anesthesia and Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Hospital General Universitario Gregorio Marañon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Laparoscopy, Anesthesia, Epidural
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group: open surgery under general anesthesia
Arm Title
Epidural group
Arm Type
Active Comparator
Arm Description
Epidural group: Open surgery under thoracic epidural anesthesia
Arm Title
Laparoscopic group
Arm Type
Active Comparator
Arm Description
Laparoscopic group: Laparoscopic surgery under general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic technique and thoracic epidural anesthesia
Intervention Description
We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques
Primary Outcome Measure Information:
Title
Plasma levels of several cytokines after colorectal cancer surgery
Description
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.
Time Frame
within the first two days after surgery
Secondary Outcome Measure Information:
Title
Incidence of adverse clinical outcomes between groups
Description
We have analyzed if there is any significant difference on respiratory, cardiac, renal or infectious postoperative complications between groups
Time Frame
within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Duque, MD
Organizational Affiliation
Gregorio Marañon Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gregorio Marañon Hospital
City
Madrid
ZIP/Postal Code
28007
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Inflammatory Response After Colorectal Cancer Surgery
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