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

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ClinicalTrials.gov Identifier: NCT01938313
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hyung-Ho Kim, Seoul National University Bundang Hospital

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: ERAS perioperative cares Procedure: Conventional perioperative cares Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study))
Study Start Date : August 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938313


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Geynggi, Korea, Republic of
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Hyung-Ho Kim, M.D., Ph.D. Department of Surgery, SNUBH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hyung-Ho Kim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01938313     History of Changes
Other Study ID Numbers: SNUBH-ERAS-GC-PII
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hyung-Ho Kim, Seoul National University Bundang Hospital:
gastric cancer
ERAS (early recovery after surgery)
fast track
laparoscopic gastrectomy

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases