NCT01819688CompletedNot Applicable
Surgical Stress Induced Insulin Resistance and Cytokine Response After Laparoscopic Compared to Open Liver Resection
Sir Run Run Shaw Hospital1 site in 1 country52 target enrollmentStarted: August 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sir Run Run Shaw Hospital
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- postoperative insulin resistance calculated by serum insulin and blood glucose
Study Overview
Brief Summary
The purpose of this study is to determine whether the postoperative insulin resistance and cytokine release would be attenuated in laparoscopic compared with open liver resection.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •left hemihepatectomy(liver resection)
- •left lateral sectionectomy(liver resection)
Exclusion Criteria
- •Patients with diabetes mellitus
- •drug abuse
- •BMI >24 or <18
Outcomes
Primary Outcomes
postoperative insulin resistance calculated by serum insulin and blood glucose
Time Frame: within the first 72hrs after operation
At baseline prior to surgery, and 3hr, 12hr, 24hr, 72hrs after operation, blood glucose and insulin was measured. Insulin resistance is assessed by the HOMAIR(homeostatic model assessment of insulin resistance) score which is calculated through the mathematic formula: HOMAIR= FI ×FG/22.5, where FI= fasting serum insulin(μU/mL), FG= fasting plasma glucose (mmol/L), and 22.5 is a constant.
Secondary Outcomes
- cytokine changement including IL-1β, IFN-γ, IL-4 and IL-10 before and after operation(within 5 days after operation)
Investigators
Chun-Yan Yan
M.D. , Ph.D
Sir Run Run Shaw Hospital
Study Sites (1)
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