Inflammatory Response After Colorectal Cancer Surgery (CRC)

Universidad Complutense de Madrid

Status: Completed

Conditions: Colorectal Cancer

Treatments: Procedure: Laparoscopic technique and thoracic epidural anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01427647

Complutense University 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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63 participants in 3 patient groups

Control group

Active Comparator group

Description:

Control group: open surgery under general anesthesia

Treatment:

Procedure: Laparoscopic technique and thoracic epidural anesthesia

Epidural group

Active Comparator group

Description:

Epidural group: Open surgery under thoracic epidural anesthesia

Treatment:

Procedure: Laparoscopic technique and thoracic epidural anesthesia

Laparoscopic group

Active Comparator group

Description:

Laparoscopic group: Laparoscopic surgery under general anesthesia

Treatment:

Procedure: Laparoscopic technique and thoracic epidural anesthesia