Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy

Study Overview
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Brief Summary
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The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .

Detailed Description
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The ERAS programs has been proved to be a useful solutions in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment. But few studies reported about the ERAS programs in the laparoscopic hepatectomy. The purpose of this study is to investigate the clinical value of enhanced recovery after surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days comparing with traditional care .

Official Title
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A Randomized Controlled Trial of Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy

Conditions
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Liver Diseases

Intervention / Treatment
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* Procedure: ERAS perioperative cares
* Procedure: Conventional perioperative cares


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: If patients were diagnosed with tumors Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ The tumor location and size do not affect the dissection of hepatic hilar region Tumor size less than 10cm Without portal vein tumor thrombus Without intrahepatic or distant metastasis Partial resection or half liver resection Willingness to participate in the study Able to understand the nature of the study and what will be required of them Body mass index of between 18 and 35 Child-Pugh classification of A to B American Society of Anesthesiologists (ASA) grading of I to III Exclusion Criteria: Pregnant or lactating women Unwillingness to participate Inability to give written informed consent Child-Pugh classification of C ASA grading of IV to V Tumor invasion of the inferior vena cava or confluence part of hepatic vein Decompensated liver cirrhosis

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 |
| --- | --- |
| Active Comparator: enhanced recovery after surgery protocal<br>ERAS perioperative cares patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols. | Procedure: ERAS perioperative cares<br>* Patient's preoperative counseling & education before surgery No Bowel preparation Drug: Oral Carbohydrate Solution (OCS). Take 250ml OCS orally 2 hours before surgery Fluid restriction & Management by pulse contour analysis or transesophageal doppler Early mobilization Early oral feeding (postoperative 1 day - liquid diet, 2 days - semifluid diet (SFD), 3 days - normal diet) Intravenous patient controlled analgesics (no opioids analgesics) Postoperative Nausea Active Control No nasogastric tube No drain insertion Patients will be discharged at POD#4 if there's no problem<br>|
| Active Comparator: Conventional perioperative cares<br>Conventional perioperative cares patents will be managed by our hospital's critical pathways. | Procedure: Conventional perioperative cares<br>* No Patient's preoperative counseling & education before surgery Bowel preparation No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery Conventional Fluid Management by clinical signs (Urine output, heart rate etc.) Conventional Mobilization Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD) IV PCA Postoperative Nausea Control if needed No Thromboembolism prophylaxis No or Low Content Oxygen therapy Drainage tube insertion if needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative hospital stay | participants will be followed for the duration of hospital stay, an expected average of 6 days | up to 4 weeks after surgery | 
| Recovering Rate | No major complication Tolerance of semiliquid diet Normal activity Good pain control with analgesic-free or oral analgesics. | 6 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to functional recovery (days from operation to functional recovery) | Normal or decreasing serum bilirubin Good pain control with oral analgesia only Tolerance of solid food No intravenous fluids Mobile independently or at the preoperative level All of the above is functional recovery. | up to 4 weeks after surgery | 
| cost of hospitalization | medical expense | up to 1 month after surgery | 
| Quality of life | EQ-5d health questionnaire and Kolcaba's GCQ (General Comfort Questionnaire), before the operation, on postoperation 1 day, postoperation 3 day, postoperation 5 day, postoperation 1 month | up to 1 month after surgery | 
| operation time |  | the day of surgery | 
| associated cytokines in peripheral blood (IL-6, IL-10 and TNF-α) | associated cytokines in peripheral blood were tested on preoperation, postoperation Day1, postoperation Day2, postoperation Day4 | before the operation, on postoperation 1 day, postoperation 2 day, postoperation 4 day | 
| liver function | liver function were tested on preoperation, postoperation Day1, postoperation Day2, postoperation Day4, postoperation 1 month if PT ≥ 50% and TB ≥ 50 μmol/L， it supports the liver dysfunction. | up to 1 month after surgery | 
| Visual Analog Score for pain | postoperative 2hours, 6 hours, 1 days, 2 days, 3 days, 4 days and 5 days | up to 5 days after surgery | 
| Estimated blood loss | blood loss during the operation | the day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enhanced recovery after surgery protocal, laparoscopic hepatectomy