A Randomized Controlled Trial of Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sir Run Run Shaw Hospital
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Recovering Rate
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
enhanced recovery after surgery protocal
ERAS perioperative cares patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.
Intervention: ERAS perioperative cares (Procedure)
Conventional perioperative cares
Conventional perioperative cares patents will be managed by our hospital's critical pathways.
Intervention: Conventional perioperative cares (Procedure)
Outcomes
Primary Outcomes
Recovering Rate
Time Frame: 6 days after surgery
1. No major complication 2. Tolerance of semiliquid diet 3. Normal activity 4. Good pain control with analgesic-free or oral analgesics.
post-operative hospital stay
Time Frame: up to 4 weeks after surgery
participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary Outcomes
- cost of hospitalization(up to 1 month after surgery)
- associated cytokines in peripheral blood (IL-6, IL-10 and TNF-α)(before the operation, on postoperation 1 day, postoperation 2 day, postoperation 4 day)
- Estimated blood loss(the day of surgery)
- Time to functional recovery (days from operation to functional recovery)(up to 4 weeks after surgery)
- Quality of life(up to 1 month after surgery)
- Visual Analog Score for pain(up to 5 days after surgery)
- liver function(up to 1 month after surgery)
- operation time(the day of surgery)
Investigators
Xiujun Cai
President
Sir Run Run Shaw Hospital