Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy

Zhejiang University

Status: Completed

Conditions: Liver Diseases

Treatments: Procedure: ERAS perioperative cares; Procedure: Conventional perioperative cares

Study type: Interventional

Funder types: Other

Identifiers

NCT02533193

sirrrsh20150802-1

Details and patient eligibility

About

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 .

Full 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 .

Enrollment: 126 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

enhanced recovery after surgery protocal

Active Comparator group

Description:

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

Treatment:

Procedure: ERAS perioperative cares

Conventional perioperative cares

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional perioperative cares