Inflammatory Response After Colorectal Cancer Surgery

Colorectal Cancer Clinical Trial

— CRC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427647
• Other study ID #: Complutense University 1
• Status: Completed
• Phase: N/A
• First received: August 29, 2011
• Last updated: July 21, 2016
• Start date: June 2007
• Est. completion date: February 2010

Study information

• Verified date: July 2016
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Gregorio Marañon Hospital	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes