Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533193
• Other study ID #: sirrrsh20150802-1
• Status: Completed
• Phase: N/A
• First received: August 11, 2015
• Last updated: September 13, 2016
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Sir Run Run Shaw Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• If patients were diagnosed with tumors

1. Located at segment ?????b?? or ?

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
China	Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Recovering Rate	No major complication; Tolerance of semiliquid diet; Normal activity; Good pain control with analgesic-free or oral analgesics.	6 days after surgery	Yes
Secondary	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	Yes
Secondary	cost of hospitalization	medical expense	up to 1 month after surgery	Yes
Secondary	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	No
Secondary	operation time		the day of surgery	Yes
Secondary	associated cytokines in peripheral blood (IL-6, IL-10 and TNF-a)	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Estimated blood loss	blood loss during the operation	the day of surgery	Yes