Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy

Not Applicable

Completed

• Conditions: Liver Diseases
• Interventions: Procedure: Conventional perioperative cares; Procedure: ERAS perioperative cares

• Registration Number: NCT02533193
• Lead Sponsor: Sir Run Run Shaw Hospital

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-22
• Study First Posted: 2015-08-26
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• If patients were diagnosed with tumors

  1. Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ
  2. The tumor location and size do not affect the dissection of hepatic hilar region
  3. Tumor size less than 10cm
  4. Without portal vein tumor thrombus
  5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional perioperative cares	Conventional perioperative cares	Conventional perioperative cares patents will be managed by our hospital's critical pathways.
enhanced recovery after surgery protocal	ERAS perioperative cares	ERAS perioperative cares patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.

Primary Outcome Measures

Name	Time	Method
Recovering Rate	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	up to 4 weeks after surgery	participants will be followed for the duration of hospital stay, an expected average of 6 days

Secondary Outcome Measures

Name	Time	Method
cost of hospitalization	up to 1 month after surgery	medical expense
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	associated cytokines in peripheral blood were tested on preoperation, postoperation Day1, postoperation Day2, postoperation Day4
Estimated blood loss	the day of surgery	blood loss during the operation
Time to functional recovery (days from operation to functional recovery)	up to 4 weeks after surgery	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.
Quality of life	up to 1 month after surgery	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
Visual Analog Score for pain	up to 5 days after surgery	postoperative 2hours, 6 hours, 1 days, 2 days, 3 days, 4 days and 5 days
liver function	up to 1 month after surgery	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.
operation time	the day of surgery

Trial Locations

Locations (1)

Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China