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OpenTrials
Completed

NCT Number: NCT01819688

Surgical Stress After Laparoscopic Compared to Open Liver Resection

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, Zhejiang, 310016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic liver resection

Procedure

Primary outcomes

  1. 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

  1. cytokine changement including IL-1β, IFN-γ, IL-4 and IL-10 before and after operation

    Time frame: within 5 days 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.

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 27, 2013
Registry last updated
Mar 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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