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Completed

NCT Number: NCT02533193

Enhanced Recovery After Surgery Protocal Versus Traditional Care in 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 .

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Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, Zhejiang, 310000, China

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERAS perioperative cares

Procedure
  • 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

Procedure
  • 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 outcomes

  1. post-operative hospital stay

    Time frame: up to 4 weeks after surgery

    participants will be followed for the duration of hospital stay, an expected average of 6 days

  2. Recovering Rate

    Time frame: 6 days after surgery

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

Secondary outcomes

  1. Time to functional recovery (days from operation to functional recovery)

    Time frame: up to 4 weeks after surgery

    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.

  2. cost of hospitalization

    Time frame: up to 1 month after surgery

    medical expense

  3. Quality of life

    Time frame: up to 1 month after surgery

    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

  4. operation time

    Time frame: the day of surgery

  5. associated cytokines in peripheral blood (IL-6, IL-10 and TNF-α)

    Time frame: before the operation, on postoperation 1 day, postoperation 2 day, postoperation 4 day

    associated cytokines in peripheral blood were tested on preoperation, postoperation Day1, postoperation Day2, postoperation Day4

  6. liver function

    Time frame: up to 1 month after surgery

    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.

  7. Visual Analog Score for pain

    Time frame: up to 5 days after surgery

    postoperative 2hours, 6 hours, 1 days, 2 days, 3 days, 4 days and 5 days

  8. Estimated blood loss

    Time frame: the day of surgery

    blood loss during the operation

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 26, 2015
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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