Laparoscopic Anatomical Hepatectomy With Intrahepatic Glisson's Approach Versus Laparoscopic Anatomical Hepatectomy With Classical Procedure
Background: China is the high incidence area of liver disease, some of which need to be
treated by surgical liver resection. The development of minimal invasive techniques opened
up a new situation for hepatectomy. Intrahepatic Glisson's approach and the classical
procedure are the two major operation procedures used in laparoscopic hepatectomy. The
intrahepatic Glisson's approach has the advantages of less intraoperative bleeding and
shorter operation time in our experience and as previous studies. The investigators expect
further comparison of the safety and efficacy through this prospective controlled study by
using two kinds of operation procedures.
Intervention: Classical procedure versus intrahepatic Glisson's approach: a prospective
randomized study. Eighty patients with liver disease need undergo hepatectomy were selected
and divided into intrahepatic Glisson's group and classical procedure group randomly, each
group contains 40 cases. Total laparoscopic hepatectomy were performed, with the
intrahepatic Glisson's approach or classical procedure respectively.
Results:
1. Clinical data include: operation time, intraoperative blood loss, volume of blood
transfusion, complications and mortality, postoperative liver function,long-term
curative effect were collected and analysed.
2. Statistical method: groups t-test univariate/multivariate analysis, logistic regression
analysis, mixed linear regression, Cox survival analysis were used.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Number of participants with operation complication
Operation time, intraoperative blood loss, volume of blood transfusion, complications and mortality, postoperative liver function were collected and analysed to evaluate the safety of the operation.
Duration hospitalization(an expected average of 8 days)
Yes
Shuguo Zheng
Study Director
Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
China: Ministry of Health
SWHZSG002
NCT01567631
January 2012
December 2017
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