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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02326727
Other study ID # 0095-14-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 10, 2014
Last updated December 22, 2014
Start date April 2015
Est. completion date May 2017

Study information

Verified date December 2014
Source Hillel Yaffe Medical Center
Contact Leonid Reytman, MD
Phone 972-4-6304257
Email lrey@netvision.net.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Regional anesthesia may decrease the release of endogenous opioids, increase Natural Killer cell (NK) function and decrease development of metastasis. The recent analysis of the Cancer Registry has noted an improved 5-year survival in patients who received epidural analgesia during surgery for colorectal carcinoma.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date May 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing colonic cancer surgery

Exclusion Criteria:

- Patients with poor physical status Patients needed emergency surgery Coagulopathic disorders with international normalized ratio (INR) level more than 1.4 Thrombocytopenia with platelets count less 100000 per mcl Allergic reaction to local anesthetics in patient history Failure to performing the epidural analgesia from another cause Preoperative immunomodulating treatment Recent history of chemotherapy or radiation therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ropivacaine
Epidural analgesia
Fentanyl
General Anesthesia
Propofol
General Anesthesia
Isoflurane
General Anesthesia
Nitrous Oxide
General Anesthesia

Locations

Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Count of live and dead target erythroleukemic cells All clinical and laboratory parameters from blood samples taken before and after the operation will be compared between the two groups of patients. The nominal data comparison will be performed by ANOVA test, and the nonparametric data will be performed by Mann-Whitney test and interquartile ranges (IQR) for non-normally distributed data. 72 hours No
Primary Plasma concentration of cytokines All clinical and laboratory parameters from blood samples taken before and after the operation will be compared between the two groups of patients. The nominal data comparison will be performed by ANOVA test, and the nonparametric data will be performed by Mann-Whitney test and interquartile ranges (IQR) for non-normally distributed data. 72 hours No
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