Inflammatory Response After Colorectal Cancer Surgery (CRC)
This study has been completed.
Sponsor:
Complutense University
Collaborator:
Hospital General Universitario Gregorio Marañon
Information provided by (Responsible Party):
Patricia Duque, M.D., Complutense University
ClinicalTrials.gov Identifier:
NCT01427647
First received: August 29, 2011
Last updated: August 31, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Procedure: Laparoscopic technique and thoracic epidural anesthesia |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Factorial Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Inflammatory Response Following Colorectal Cancer Surgery Depends on the Type of Anesthesia and Surgery |
Resource links provided by NLM:
Further study details as provided by Complutense University:
Primary Outcome Measures:
- Plasma levels of several cytokines after colorectal cancer surgery [ Time Frame: within the first two days after surgery ] [ Designated as safety issue: No ]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 Outcome Measures:
- Incidence of adverse clinical outcomes between groups [ Time Frame: within 30 days after surgery ] [ Designated as safety issue: Yes ]We have analyzed if there is any significant difference on respiratory, cardiac, renal or infectious postoperative complications between groups
| Enrollment: | 63 |
| Study Start Date: | June 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427647
Locations
| Spain | |
| Gregorio Marañon Hospital | |
| Madrid, Spain, 28007 | |
Sponsors and Collaborators
Complutense University
Hospital General Universitario Gregorio Marañon
Investigators
| Principal Investigator: | Patricia Duque, MD | Gregorio Marañon Hospital |
More Information
No publications provided
| Responsible Party: | Patricia Duque, M.D., Anesthesiologist staff, Complutense University |
| ClinicalTrials.gov Identifier: | NCT01427647 History of Changes |
| Other Study ID Numbers: | Complutense University 1 |
| Study First Received: | August 29, 2011 |
| Last Updated: | August 31, 2011 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Complutense University:
|
Laparoscopy Anesthesia, Epidural |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013