search
Back to results

Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy

Primary Purpose

Liver Diseases

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ERAS perioperative cares
Conventional perioperative cares
Sponsored by
Sir Run Run Shaw Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Diseases focused on measuring enhanced recovery after surgery protocal, laparoscopic hepatectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

enhanced recovery after surgery protocal

Conventional perioperative cares

Arm Description

ERAS perioperative cares patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.

Conventional perioperative cares patents will be managed by our hospital's critical pathways.

Outcomes

Primary Outcome Measures

post-operative hospital stay
participants will be followed for the duration of hospital stay, an expected average of 6 days
Recovering Rate
No major complication Tolerance of semiliquid diet Normal activity Good pain control with analgesic-free or oral analgesics.

Secondary Outcome Measures

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.
cost of hospitalization
medical expense
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
operation time
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
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.
Visual Analog Score for pain
postoperative 2hours, 6 hours, 1 days, 2 days, 3 days, 4 days and 5 days
Estimated blood loss
blood loss during the operation

Full Information

First Posted
August 11, 2015
Last Updated
September 13, 2016
Sponsor
Sir Run Run Shaw Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02533193
Brief Title
Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy
Official Title
A Randomized Controlled Trial of Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Run Run Shaw Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases
Keywords
enhanced recovery after surgery protocal, laparoscopic hepatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
enhanced recovery after surgery protocal
Arm Type
Active Comparator
Arm Description
ERAS perioperative cares patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.
Arm Title
Conventional perioperative cares
Arm Type
Active Comparator
Arm Description
Conventional perioperative cares patents will be managed by our hospital's critical pathways.
Intervention Type
Procedure
Intervention Name(s)
ERAS perioperative cares
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Conventional perioperative cares
Intervention Description
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
Primary Outcome Measure Information:
Title
post-operative hospital stay
Description
participants will be followed for the duration of hospital stay, an expected average of 6 days
Time Frame
up to 4 weeks after surgery
Title
Recovering Rate
Description
No major complication Tolerance of semiliquid diet Normal activity Good pain control with analgesic-free or oral analgesics.
Time Frame
6 days after surgery
Secondary Outcome Measure Information:
Title
Time to functional recovery (days from operation to functional recovery)
Description
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
Title
cost of hospitalization
Description
medical expense
Time Frame
up to 1 month after surgery
Title
Quality of life
Description
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
Title
operation time
Time Frame
the day of surgery
Title
associated cytokines in peripheral blood (IL-6, IL-10 and TNF-α)
Description
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
Title
liver function
Description
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
Title
Visual Analog Score for pain
Description
postoperative 2hours, 6 hours, 1 days, 2 days, 3 days, 4 days and 5 days
Time Frame
up to 5 days after surgery
Title
Estimated blood loss
Description
blood loss during the operation
Time Frame
the day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy

We'll reach out to this number within 24 hrs