Clinical trial NCT01768728: Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions
Official title: A Randomized Controlled Trial of Acute Surgical Trauma and Stress Response of Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Lesions in Left Liver
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma C-reactive protein (CRP) level
timeFrame: up to 7 days
Secondary outcomes:
measure: Inflammatory response markers including interleukin-6, interleukin-10 concentrations and tumor necrosis factor α level in serum
timeFrame: up to 7 days
measure: Oxidative stress status including plasma malondialdehyde level and total antioxidant capacity
timeFrame: up to 7 days
measure: Immune status including white blood cell count and human leukocyte antigen DR (HLA-DR) expression
timeFrame: up to 7 days
measure: Status of insulin resistant
timeFrame: up to 7 days
measure: Systemic inflammatory response syndrome
timeFrame: up to 7 days
measure: Status of hepatic cell apoptosis including hematoxylin and eosin (HE) staining, immunohistochemistry staining and caspase-3 expression
timeFrame: 24 hours
measure: Time to functional recovery
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Postoperative hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
measure: Morbidity and mortality
timeFrame: up to 1 month
measure: Quality of life
timeFrame: up to 1 month
measure: Intraoperative parameters including operation time, pneumoperitoneum time, liver resection time, intraoperative estimated blood loss,transfusion
timeFrame: participants will be followed for the duration of operation, an expected average of 120 minutes
Other outcomes:
measure: Hospital costs
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Locations:
city: Hangzhou
country: China
facility: Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
References: