Surgical Stress After Laparoscopic Compared to Open Liver Resection

Insulin Resistance Clinical Trial

Official title:

Surgical Stress Induced Insulin Resistance and Cytokine Response After Laparoscopic Compared to Open Liver Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819688
• Other study ID #: 20120704
• Secondary ID: (1)2009R50040 (2
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: March 22, 2013
• Start date: August 2007
• Est. completion date: November 2008

Study information

• Verified date: March 2013
• Source: Sir Run Run Shaw Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Procedure:
• laparoscopic liver resection

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within the first 72hrs after operation	Yes
Secondary	cytokine changement including IL-1ß, IFN-?, 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-1ß, IFN-?, IL-4 and IL-10.	within 5 days after operation	Yes