Inflammatory Response After Colorectal Cancer Surgery (CRC)

Inflammatory Response Following Colorectal Cancer Surgery Depends on the Type of Anesthesia and Surgery

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Laparoscopic technique and thoracic epidural 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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Gregorio Marañon hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within the first two days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within 30 days after surgery

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Hospital General Universitario Gregorio Marañon
• Investigators: Principal Investigator: Patricia Duque, MD, Gregorio Marañon hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: August 29, 2011
• First Submitted That Met QC Criteria: August 31, 2011
• First Posted (Estimate): September 1, 2011

Study Record Updates

• Last Update Posted (Estimate): July 22, 2016
• Last Update Submitted That Met QC Criteria: July 21, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Laparoscopy; Anesthesia, Epidural
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Complutense University 1