Effect of Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS) After Liver Resection for Primary Liver Cancer: a Multicenter, Randomized, Controlled Clinical Study

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Procedure: Enhanced Recovery After Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with HCC with indications for surgery Without any surgical contraindications Under went open liver resection Operation ranges less than 4 hepatic segments Informed consent Exclusion Criteria: Not suitable for surgery Benign lesions or other lesions proved by pathology Surgical procedure changed during operation or combined evisceration Refused to participate or drop out

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Recovery After Surgery<br>Patients underwent ERAS protocol | Procedure: Enhanced Recovery After Surgery<br>* 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.<br>* Other names: Fast Track Surgery;|
| No Intervention: Conventional Treatment<br>Patients underwent conventional treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related complications | Number of adverse events that are related to treatment of each patients, and hospital readmission | Up to 1 month since operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in hospital | Length of stay in hospital (days) | From the day a patient be hospitalized to the day discharged, up to 1 month. | 
| Total hospitalization costs | Total hospitalization costs (RMB yuan). | 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. | 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. | Day before operation and day 1/3/5 after operation. | 
| Albumin (ALB) | ALB in g/L. | Day before operation and day 1/3/5 after operation. | 
| PRE-Albumin (PRE-A) | PRE-A in g/L | Day before operation and day 1/3/5 after operation. | 
| International Normalized Ratio (INR) | INR in seconds. | Day before operation and day 1/3/5 after operation. | 
| Platelet (PLT) | PLT in 10^9/L | Day before operation and day 1/3/5 after operation. | 
| Blood Urea Nitrogen (BUN) | BUN in mmol/L | Day before operation and day 1/3/5 after operation. | 
| Blood Creatinine (sCr) | sCr in umol/L | Day before operation and day 1/3/5 after operation. | 
| Alanine Transferase (ALT) | ALT in U/L | Day before operation and day 1/3/5 after operation. | 
| Aspartate Transaminase (AST) | AST in U/L | Day before operation and day 1/3/5 after operation. | 
| Interleukin-6 (IL-6) | IL-6 in (pg/ml) | Day before operation and day 1/3/5 after operation. | 
| Interferon (IFN-γ) | IFN-γin pg/ml. | Day before operation and day 1/3/5 after operation. | 
| Tumor necrosis factor-α (TNF-α) | TNF-αin pg/ml | Day before operation and day 1/3/5 after operation. | 
| Serum complement | C3 and C4 in mg/dl | Day before operation and day 1/3/5 after operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enhanced Recovery After Surgery, hepatocellular carcinoma