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Completed

NCT Number: NCT01938313

Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy

Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital

Seongnam, Geynggi, South Korea

About this study

There is strong evidence of the usefulness of the ERAS programs 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.

However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.

The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective surgery
  • American Society of Anesthesiologists (ASA) scores < 3
  • 20 < Age < 80
  • Gastric cancer, adenocarcinoma, possible to perform laparoscopic distal gastrectomy
  • Informed consent
  • No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.
  • No systemic inflammatory disease

Exclusion criteria

  • Emergency operation

Treatment and study plan

ERAS perioperative cares

Procedure
  • Patient's preoperative counseling & education before surgery
  • No Bowel preparation
  • Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
  • Fluid restriction & Management by pulse contour analysis or transesophageal doppler
  • Early mobilization
  • Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD))
  • Epidural patient controlled analgesics (no opioids analgesics)
  • Postoperative Nausea Active Control
  • Thromboembolism prophylaxis by low molecular weighted heparin (LMWH)
  • Perioperative High content Oxygen therapy
  • No drain insertion
  • No Levin tube
  • 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
  • Routine drain insertion
  • Levin tube insertion if needed

Primary outcomes

  1. Recovering Rate

    Time frame: 4 days after surgery

    • Tolerance of diet for 24 hours A. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting
    • Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)
    • Safe ambulation (ambulation of 600m without assistance)
    • Afebrile status without major complications (fever defined as body temperature greater than 37.5)
    • Above total 4 criteria should be satisfied for the evaluation of complete recovery.

Secondary outcomes

  1. Postoperative length of hospital stay

    Time frame: up to 4 weeks after surgery

  2. Time to tolerance of a full diet

    Time frame: up to 1 month after surgery

  3. Time to first bowel motion Time to first bowel motion

    Time frame: up to 7 days after surgery

  4. Complications during the admissionTime to first bowel motion

    Time frame: up to 30 days after surgery

  5. Readmission rate

    Time frame: up to 30 days after surgery

  6. Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days

    Time frame: up to 3 days after surgery

    postoperative 2hours, 6 hours, 1 days, 2 days, 3 days

  7. Quality of life

    Time frame: up to 1 month after surgery

    European organization for research and treatment of cancer (EORTC) and gastrointestinal quality of life index (GIQLI) questionnaire on postoperative 5 days, 1 month

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study))

Acronym: ERAS

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Sep 10, 2013
Registry last updated
Jan 5, 2017

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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