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 .
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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
1. Patient's preoperative counseling \& education before surgery 2. No Bowel preparation 3. Drug: Oral Carbohydrate Solution (OCS). Take 250ml OCS orally 2 hours before surgery 4. Fluid restriction \& Management by pulse contour analysis or transesophageal doppler 5. Early mobilization 6. Early oral feeding (postoperative 1 day - liquid diet, 2 days - semifluid diet (SFD), 3 days - normal diet) 7. Intravenous patient controlled analgesics (no opioids analgesics) 8. Postoperative Nausea Active Control 9. No nasogastric tube 10. No drain insertion 11. Patients will be discharged at POD#4 if there's no problem
1. No Patient's preoperative counseling \& education before surgery 2. Bowel preparation 3. No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery 4. Conventional Fluid Management by clinical signs (Urine output, heart rate etc.) 5. Conventional Mobilization 6. Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD) 7. IV PCA 8. Postoperative Nausea Control if needed 9. No Thromboembolism prophylaxis 10. No or Low Content Oxygen therapy 11. Drainage tube insertion if needed
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
post-operative hospital stay
participants will be followed for the duration of hospital stay, an expected average of 6 days
Time frame: up to 4 weeks after surgery
Recovering Rate
1. No major complication 2. Tolerance of semiliquid diet 3. Normal activity 4. Good pain control with analgesic-free or oral analgesics.
Time frame: 6 days after surgery
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.
Time frame: up to 4 weeks after surgery
cost of hospitalization
medical expense
Time frame: 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
Time frame: up to 1 month after surgery
operation time
Time frame: 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
Time frame: before the operation, on postoperation 1 day, postoperation 2 day, postoperation 4 day
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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.
Time frame: 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
Time frame: up to 5 days after surgery
Estimated blood loss
blood loss during the operation
Time frame: the day of surgery