Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy

NCT02533193 | Completed

• 1 other identifier: sirrrsh20150802-1
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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 .

Conditions

Liver Diseases

Keywords

enhanced recovery after surgery protocal; laparoscopic hepatectomy

Outcome Measures

Primary Outcomes (2)

• 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

  1. No major complication 2. Tolerance of semiliquid diet 3. Normal activity 4. Good pain control with analgesic-free or oral analgesics.

  6 days after surgery

Secondary Outcomes (8)

• Time to functional recovery (days from operation to functional recovery)

  up to 4 weeks after surgery

• cost of hospitalization

  up to 1 month after surgery

• Quality of life

  up to 1 month after surgery

• operation time

  the day of 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

Study Arms (2)

enhanced recovery after surgery protocal

ACTIVE COMPARATOR

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

Procedure: ERAS perioperative cares

Conventional perioperative cares

ACTIVE COMPARATOR

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

Procedure: Conventional perioperative cares

Interventions

ERAS perioperative cares PROCEDURE

1. Patient's preoperative counseling \& education before surgery 2. No Bowel preparation 3. Drug: Oral Carbohydrate Solution (OCS). Take 250ml OCS orally 2 hours before surgery 4. Fluid restriction \& Management by pulse contour analysis or transesophageal doppler 5. Early mobilization 6. Early oral feeding (postoperative 1 day - liquid diet, 2 days - semifluid diet (SFD), 3 days - normal diet) 7. Intravenous patient controlled analgesics (no opioids analgesics) 8. Postoperative Nausea Active Control 9. No nasogastric tube 10. No drain insertion 11. Patients will be discharged at POD#4 if there's no problem

enhanced recovery after surgery protocal

Conventional perioperative cares PROCEDURE

1. No Patient's preoperative counseling \& education before surgery 2. Bowel preparation 3. No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery 4. Conventional Fluid Management by clinical signs (Urine output, heart rate etc.) 5. Conventional Mobilization 6. Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD) 7. IV PCA 8. Postoperative Nausea Control if needed 9. No Thromboembolism prophylaxis 10. No or Low Content Oxygen therapy 11. Drainage tube insertion if needed

Conventional perioperative cares

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 26, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

CN (1)