Skip to main content
OpenTrials
Completed

NCT Number: NCT01427647

Inflammatory Response After Colorectal Cancer 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gregorio Marañon Hospital

Madrid, 28007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic technique and thoracic epidural anesthesia

Procedure

We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Hospital General Universitario Gregorio Marañon

Registry information

Official study title

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

Acronym: CRC

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Sep 1, 2011
Registry last updated
Jul 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.