Inflammatory Response After Colorectal Cancer Surgery

NCT ID: NCT01427647

Last Updated: 2016-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-02-28

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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control group

Control group: open surgery under general anesthesia

Group Type ACTIVE_COMPARATOR

Laparoscopic technique and thoracic epidural anesthesia

Intervention Type PROCEDURE

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

Epidural group

Epidural group: Open surgery under thoracic epidural anesthesia

Group Type ACTIVE_COMPARATOR

Laparoscopic technique and thoracic epidural anesthesia

Intervention Type PROCEDURE

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

Laparoscopic group

Laparoscopic group: Laparoscopic surgery under general anesthesia

Group Type ACTIVE_COMPARATOR

Laparoscopic technique and thoracic epidural anesthesia

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Patricia Duque, M.D.

Anesthesiologist staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia Duque, MD

Role: PRINCIPAL_INVESTIGATOR

Gregorio Marañon Hospital

Locations

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Gregorio Marañon Hospital

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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Complutense University 1

Identifier Type: -

Identifier Source: org_study_id

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