Inflammatory Response After Colorectal Cancer Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Laparoscopic technique and thoracic epidural anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Control group: open surgery under general anesthesia | Procedure: Laparoscopic technique and thoracic epidural anesthesia<br>* We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques<br>|
| Active Comparator: Epidural group<br>Epidural group: Open surgery under thoracic epidural anesthesia | Procedure: Laparoscopic technique and thoracic epidural anesthesia<br>* We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques<br>|
| Active Comparator: Laparoscopic group<br>Laparoscopic group: Laparoscopic surgery under general anesthesia | Procedure: Laparoscopic technique and thoracic epidural anesthesia<br>* We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Anesthesia, Epidural