Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions

Not Applicable

Completed

• Conditions: Benign Lesions in Left Liver
• Interventions: Procedure: Open left hemihepatectomy; Procedure: Laparoscopic left hemihepatectomy

• Registration Number: NCT01768728
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief Summary

The purpose of this study is to investigate the influence of the laparoscopic and open left hemihepatectomy on acute surgical trauma and stress response.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-13
• Study First Posted: 2013-01-15
• Primary Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patient with benign lesions who requires left hemihepatectomy
• Child-Pugh classification of A to B
• American Society Of Anesthesiologists (ASA) grading of I to III
• a body mass index of between 18 and 35
• willingness to participate in the study
• able to understand the nature of the study and what will be required of them

Exclusion Criteria

• pregnant or lactating women
• unwillingness to participate
• Child-Pugh classification of C
• ASA grading of IV to V
• with condition of acute inflammatory,fever or diabetes mellitus
• with autoimmune disease or immunodeficiency
• taking drugs that affect the immune system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open left hemihepatectomy	Open left hemihepatectomy	Group of patients operated with open left hemihepatectomy
Laparoscopic left hemihepatectomy group	Laparoscopic left hemihepatectomy	Group of patients that are operated with laparoscopic left hemihepatectomy

Primary Outcome Measures

Name	Time	Method
Plasma C-reactive protein (CRP) level	up to 7 days	CRP will be tested before operation, 3,12,24 hours and 3,5,7 days after operation

Secondary Outcome Measures

Name	Time	Method
Quality of life	up to 1 month
Inflammatory response markers including interleukin-6, interleukin-10 concentrations and tumor necrosis factor α level in serum	up to 7 days	interleukin-6 and interleukin-10 will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
Systemic inflammatory response syndrome	up to 7 days
Oxidative stress status including plasma malondialdehyde level and total antioxidant capacity	up to 7 days	plasma malondialdehyde level and total antioxidant capacity will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
Immune status including white blood cell count and human leukocyte antigen DR (HLA-DR) expression	up to 7 days	white blood cell count and human leukocyte antigen DR (HLA-DR) expression will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
Status of insulin resistant	up to 7 days	Status of insulin resistant will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
Status of hepatic cell apoptosis including hematoxylin and eosin (HE) staining, immunohistochemistry staining and caspase-3 expression	24 hours
Time to functional recovery	Participants will be followed for the duration of hospital stay, an expected average of 7 days
Postoperative hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 8 days
Morbidity and mortality	up to 1 month
Intraoperative parameters including operation time, pneumoperitoneum time, liver resection time, intraoperative estimated blood loss,transfusion	participants will be followed for the duration of operation, an expected average of 120 minutes

Trial Locations

Locations (1)

Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China