Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy

A Randomized Controlled Trial of Enhanced Recovery After Surgery Protocal Versus Traditional Care in 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 Overview

• Status: Completed
• Conditions: Liver Diseases
• Intervention / Treatment: Procedure: ERAS perioperative cares; Procedure: Conventional perioperative cares

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 Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: enhanced recovery after surgery protocal; ERAS perioperative cares patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.	Procedure: ERAS perioperative cares; 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
Active Comparator: Conventional perioperative cares; Conventional perioperative cares patents will be managed by our hospital's critical pathways.	Procedure: Conventional perioperative cares; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 22, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: enhanced recovery after surgery protocal; laparoscopic hepatectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: sirrrsh20150802-1