Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01978717
Other study ID # NO.2011-197
Secondary ID 08431910200
Status Completed
Phase N/A
First received November 1, 2013
Last updated November 1, 2013
Start date September 2011
Est. completion date September 2012

Study information

Verified date November 2013
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority China: Science and Technology Commission of Shanghai Municipality
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date September 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 51 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
epidural anesthesia

general anesthesia
Patients received general anesthesia for surgery

Locations

Country Name City State
China Zhong Shan Hospital Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Changhong Miao

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The changes of peripheral immune cells and cytokines The changes of peripheral subtype of T-helper, myeloid-derived suppressor cells(MDSCs) and cytokines within the first 5 days after surgery Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04552093 - Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT) Phase 2/Phase 3
Completed NCT04192565 - A Prospective Investigation of the ColubrisMX ELS System N/A
Completed NCT05178745 - A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
Recruiting NCT03561350 - Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
Recruiting NCT06128798 - Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery. N/A
Recruiting NCT03602677 - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage N/A
Completed NCT03631407 - Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046) Phase 2
Withdrawn NCT04192929 - Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy N/A
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT02889679 - Underwater Resection of Non-pedunculated Colorectal Lesions N/A
Terminated NCT02842580 - De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT02564835 - Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer N/A
Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
Completed NCT02149108 - Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1) Phase 3
Completed NCT02599103 - The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects N/A
Completed NCT01669109 - Hatha Yoga for Patients With Colorectal Cancer N/A
Completed NCT01719926 - Phase I Platinum Based Chemotherapy Plus Indomethacin Phase 1
Recruiting NCT01428752 - Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer N/A
Completed NCT01877018 - Colorectal Cancer Screening in Primary Care N/A
Terminated NCT00950820 - Study to Evaluate the Effects of Panitumumab if Combined With Chemotherapy for 2nd Treatment of Colorectal Cancer Phase 2