Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Completed
NCT Number: NCT01768728
Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions
The purpose of this study is to investigate the influence of the laparoscopic and open left hemihepatectomy on acute surgical trauma and stress response.
Completed
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Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Laparoscopic left hemihepatectomy
Procedureparticipants will be performed with laparoscopic left hepatectomy using laparoscopic instruments
Other names: Laparoscopic left hepatectomy
Open left hemihepatectomy
Procedureparticipants will be performed with traditional open left hepatectomy using laparotomic instruments
Other names: Open left hepatectomy
Primary outcomes
-
Plasma C-reactive protein (CRP) level
Time frame: up to 7 days
CRP will be tested before operation, 3,12,24 hours and 3,5,7 days after operation
Secondary outcomes
-
Inflammatory response markers including interleukin-6, interleukin-10 concentrations and tumor necrosis factor α level in serum
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 7 days
-
Status of hepatic cell apoptosis including hematoxylin and eosin (HE) staining, immunohistochemistry staining and caspase-3 expression
Time frame: 24 hours
-
Time to functional recovery
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
-
Postoperative hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
-
Morbidity and mortality
Time frame: up to 1 month
-
Quality of life
Time frame: up to 1 month
-
Intraoperative parameters including operation time, pneumoperitoneum time, liver resection time, intraoperative estimated blood loss,transfusion
Time frame: participants will be followed for the duration of operation, an expected average of 120 minutes
Other outcomes
-
Hospital costs
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Sponsors and collaborators
Lead sponsor
Sir Run Run Shaw Hospital
Other
Registry information
Official study title
A Randomized Controlled Trial of Acute Surgical Trauma and Stress Response of Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions
Important dates
- Study start
- 2012
- Primary completion
- 2015
- First posted
- Jan 15, 2013
- Registry last updated
- Nov 18, 2015
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.