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General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer

NCT ID: NCT01978717

Last Updated: 2013-11-07

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

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to prove whether general anesthesia combined with epidural anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the prognosis.

Detailed Description

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Conditions

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Colorectal Neoplasms

Keywords

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Anesthesia T-helper MDSCs Colorectal cancer Fast track

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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general anesthesia & epidural anesthesia

26 patients received general anesthesia combined with epidural anesthesia for surgery, and patient-controlled epidural analgesia for 2 days after surgery

Group Type EXPERIMENTAL

epidural anesthesia

Intervention Type PROCEDURE

general anesthesia

Intervention Type PROCEDURE

Patients received general anesthesia for surgery

general anesthesia

27 patients received general anesthesia for surgery, and patient-controlled intravenous analgesia for 2 days after surgery

Group Type EXPERIMENTAL

general anesthesia

Intervention Type PROCEDURE

Patients received general anesthesia for surgery

Interventions

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epidural anesthesia

Intervention Type PROCEDURE

general anesthesia

Patients received general anesthesia for surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with Colorectal Cancer(CRC);
* subjected to the Fast-Track processing of surgery;
* between 18 and 75 years old.

Exclusion Criteria

* American Society of Anesthesiologists(ASA) grade \> III;
* BMI \> 30;
* a history of abdominal surgery, endocrine or immune system dysfunction;
* recent blood transfusions, hormone or non-steroidal anti-inflammatory therapy during the past month;
* previous contraindication to epidural anesthesia.
Minimum Eligible Age

51 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhong Miao

OTHER

Sponsor Role lead

Responsible Party

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Changhong Miao

Professor, Department of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Zhong Shan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Chen WK, Miao CH. The effect of anesthetic technique on survival in human cancers: a meta-analysis of retrospective and prospective studies. PLoS One. 2013;8(2):e56540. doi: 10.1371/journal.pone.0056540. Epub 2013 Feb 20.

Reference Type BACKGROUND
PMID: 23437162 (View on PubMed)

Other Identifiers

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08431910200

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NO.2011-197

Identifier Type: -

Identifier Source: org_study_id