The purpose of this study is to evaluate Enhanced Recovery After Surgery(ERAS) protocol versus conventional treatment on patients who underwent liver resection for hepatocellular carcinoma(HCC).
212 patients are randomly recruited from inpatients of Shanghai Zhongshan Hospital, Eastern Hepatobiliary Surgery Hospital, RenJi Hospital, Anhui Provincial Hospital, Subei People's Hospital of Jiangsu Province and Affiliated Tumor Hospital of Nantong University from February 2016 to July 2016. Randomly assigned about half of the patients to receive Enhanced Recovery After Surgery(ERAS) protocol and the other half to receive conventional treatment. Evaluate the safety and efficacy of the ERAS protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
214
Before operation: Preoperative optimization of organ function, No preoperative bowel preparation, Prohibit eating 6h, drinking water 2h before operation, Oral rehydration before operation. In operation: Optimized combined anesthesia, Minimal invasive operations, Normothermia, Minimal use of tubes and drains. After operation: Postoperative analgesia and antiemetic, Early mobilization, Oral nutrition, Early and scheduled mobilization.
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Treatment related complications
Number of adverse events that are related to treatment of each patients, and hospital readmission
Time frame: Up to 1 month since operation
Length of stay in hospital
Length of stay in hospital (days)
Time frame: From the day a patient be hospitalized to the day discharged, up to 1 month.
Total hospitalization costs
Total hospitalization costs (RMB yuan).
Time frame: From the day a patient be hospitalized to the day discharged, up to 1 month.
Preoperative and postoperative body weight
Patient's body weight in kg.
Time frame: One day before operation, and the day patient discharged, up to 1 month.
Hemoglobin (Hb) test Hb/ALB/PRE-A(g/L),
Hb in g/L.
Time frame: Day before operation and day 1/3/5 after operation.
Albumin (ALB)
ALB in g/L.
Time frame: Day before operation and day 1/3/5 after operation.
PRE-Albumin (PRE-A)
PRE-A in g/L
Time frame: Day before operation and day 1/3/5 after operation.
International Normalized Ratio (INR)
INR in seconds.
Time frame: Day before operation and day 1/3/5 after operation.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Platelet (PLT)
PLT in 10\^9/L
Time frame: Day before operation and day 1/3/5 after operation.
Blood Urea Nitrogen (BUN)
BUN in mmol/L
Time frame: Day before operation and day 1/3/5 after operation.
Blood Creatinine (sCr)
sCr in umol/L
Time frame: Day before operation and day 1/3/5 after operation.
Alanine Transferase (ALT)
ALT in U/L
Time frame: Day before operation and day 1/3/5 after operation.
Aspartate Transaminase (AST)
AST in U/L
Time frame: Day before operation and day 1/3/5 after operation.
Interleukin-6 (IL-6)
IL-6 in (pg/ml)
Time frame: Day before operation and day 1/3/5 after operation.
Interferon (IFN-γ)
IFN-γin pg/ml.
Time frame: Day before operation and day 1/3/5 after operation.
Tumor necrosis factor-α (TNF-α)
TNF-αin pg/ml
Time frame: Day before operation and day 1/3/5 after operation.
Serum complement
C3 and C4 in mg/dl
Time frame: Day before operation and day 1/3/5 after operation.