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Surgical Stress After Laparoscopic Compared to Open Liver Resection

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic liver resection
Sponsored by
Sir Run Run Shaw Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Insulin Resistance focused on measuring laparoscopic liver resection, cytokine release

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA 1-2
  • left hemihepatectomy(liver resection)
  • left lateral sectionectomy(liver resection)

Exclusion Criteria:

  • Patients with diabetes mellitus
  • drug abuse
  • BMI >24 or <18

Sites / Locations

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Outcomes

Primary Outcome Measures

postoperative insulin resistance calculated by serum insulin and blood glucose
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 Outcome Measures

cytokine changement including IL-1β, IFN-γ, IL-4 and IL-10 before and after operation
At baseline before operation and 0, 3hr, 12hr, 24hr, D3, D5 after operation, duplicated samples were drawn to analyze serum IL-1β, IFN-γ, IL-4 and IL-10.

Full Information

First Posted
March 20, 2013
Last Updated
March 22, 2013
Sponsor
Sir Run Run Shaw Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01819688
Brief Title
Surgical Stress After Laparoscopic Compared to Open Liver Resection
Official Title
Surgical Stress Induced Insulin Resistance and Cytokine Response After Laparoscopic Compared to Open Liver Resection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Run Run Shaw Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
laparoscopic liver resection, cytokine release

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
laparoscopic liver resection
Primary Outcome Measure Information:
Title
postoperative insulin resistance calculated by serum insulin and blood glucose
Description
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.
Time Frame
within the first 72hrs after operation
Secondary Outcome Measure Information:
Title
cytokine changement including IL-1β, IFN-γ, IL-4 and IL-10 before and after operation
Description
At baseline before operation and 0, 3hr, 12hr, 24hr, D3, D5 after operation, duplicated samples were drawn to analyze serum IL-1β, IFN-γ, IL-4 and IL-10.
Time Frame
within 5 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA 1-2 left hemihepatectomy(liver resection) left lateral sectionectomy(liver resection) Exclusion Criteria: Patients with diabetes mellitus drug abuse BMI >24 or <18
Facility Information:
Facility Name
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China

12. IPD Sharing Statement

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Surgical Stress After Laparoscopic Compared to Open Liver Resection

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