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

January 4, 2017 updated by: Hyung-Ho Kim, Seoul National University Bundang Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Geynggi
      • Seongnam, Geynggi, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ERAS perioperative cares
Patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.
Procedure: ERAS perioperative cares
  1. Patient's preoperative counseling & education before surgery
  2. No Bowel preparation
  3. Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
  4. Fluid restriction & Management by pulse contour analysis or transesophageal doppler
  5. Early mobilization
  6. Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD))
  7. Epidural patient controlled analgesics (no opioids analgesics)
  8. Postoperative Nausea Active Control
  9. Thromboembolism prophylaxis by low molecular weighted heparin (LMWH)
  10. Perioperative High content Oxygen therapy
  11. No drain insertion
  12. No Levin tube
  13. Patients will be discharged at POD#4 if there's no problem.
Active Comparator: Conventional perioperative cares
Patents will be managed by our hospital's critical pathways.
Procedure: Conventional perioperative cares
  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. Routine drain insertion
  12. Levin tube insertion if needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovering Rate
Time Frame: 4 days after surgery
  1. 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
  2. Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)
  3. Safe ambulation (ambulation of 600m without assistance)

  4. 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.
4 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative length of hospital stay
Time Frame: up to 4 weeks after surgery
up to 4 weeks after surgery
Time to tolerance of a full diet
Time Frame: up to 1 month after surgery
up to 1 month after surgery
Time to first bowel motion Time to first bowel motion
Time Frame: up to 7 days after surgery
up to 7 days after surgery
Complications during the admissionTime to first bowel motion
Time Frame: up to 30 days after surgery
up to 30 days after surgery
Readmission rate
Time Frame: up to 30 days after surgery
up to 30 days after surgery
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
up to 3 days after surgery
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
up to 1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Hyung-Ho Kim, M.D., Ph.D., Department of Surgery, SNUBH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

July 15, 2012

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

January 5, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-ERAS-GC-PII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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