Benign Lesions in Left Liver
Conditions
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.
Interventions
PROCEDURELaparoscopic left hemihepatectomy
participants will be performed with laparoscopic left hepatectomy using laparoscopic instruments
PROCEDUREOpen left hemihepatectomy
participants will be performed with traditional open left hepatectomy using laparotomic instruments
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Systemic inflammatory response syndrome | up to 7 days | — |
| 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 | — |
| Quality of life | 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 | — |
| Status of hepatic cell apoptosis including hematoxylin and eosin (HE) staining, immunohistochemistry staining and caspase-3 expression | 24 hours | — |
Other
| Measure | Time frame |
|---|---|
| Hospital costs | Participants will be followed for the duration of hospital stay, an expected average of 10 days |
Countries
China
Outcome results
None listed