Clinical trial NCT02533193: 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
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases
Keywords: enhanced recovery after surgery protocal
laparoscopic hepatectomy
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: post-operative hospital stay
timeFrame: up to 4 weeks after surgery
measure: Recovering Rate
timeFrame: 6 days after surgery
Secondary outcomes:
measure: Time to functional recovery (days from operation to functional recovery)
timeFrame: up to 4 weeks after surgery
measure: cost of hospitalization
timeFrame: up to 1 month after surgery
measure: Quality of life
timeFrame: up to 1 month after surgery
measure: operation time
timeFrame: the day of surgery
measure: associated cytokines in peripheral blood (IL-6, IL-10 and TNF-α)
timeFrame: before the operation, on postoperation 1 day, postoperation 2 day, postoperation 4 day
measure: liver function
timeFrame: up to 1 month after surgery
measure: Visual Analog Score for pain
timeFrame: up to 5 days after surgery
measure: Estimated blood loss
timeFrame: the day of surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
References: