Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy (ERAS)
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ERAS perioperative cares
Conventional perioperative cares
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, ERAS (early recovery after surgery), fast track, laparoscopic gastrectomy
Eligibility 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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ERAS perioperative cares
Conventional perioperative cares
Arm Description
Patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.
Patents will be managed by our hospital's critical pathways.
Outcomes
Primary Outcome Measures
Recovering Rate
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 Outcome Measures
Postoperative length of hospital stay
Time to tolerance of a full diet
Time to first bowel motion Time to first bowel motion
Complications during the admissionTime to first bowel motion
Readmission rate
Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days
postoperative 2hours, 6 hours, 1 days, 2 days, 3 days
Quality of life
European organization for research and treatment of cancer (EORTC) and gastrointestinal quality of life index (GIQLI) questionnaire on postoperative 5 days, 1 month
Full Information
NCT ID
NCT01938313
First Posted
July 15, 2012
Last Updated
January 4, 2017
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01938313
Brief Title
Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy
Acronym
ERAS
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 Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, ERAS (early recovery after surgery), fast track, laparoscopic gastrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERAS perioperative cares
Arm Type
Active Comparator
Arm Description
Patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.
Arm Title
Conventional perioperative cares
Arm Type
Active Comparator
Arm Description
Patents will be managed by our hospital's critical pathways.
Intervention Type
Procedure
Intervention Name(s)
ERAS perioperative cares
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional perioperative cares
Intervention Description
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 Outcome Measure Information:
Title
Recovering Rate
Description
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.
Time Frame
4 days after surgery
Secondary Outcome Measure Information:
Title
Postoperative length of hospital stay
Time Frame
up to 4 weeks after surgery
Title
Time to tolerance of a full diet
Time Frame
up to 1 month after surgery
Title
Time to first bowel motion Time to first bowel motion
Time Frame
up to 7 days after surgery
Title
Complications during the admissionTime to first bowel motion
Time Frame
up to 30 days after surgery
Title
Readmission rate
Time Frame
up to 30 days after surgery
Title
Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days
Description
postoperative 2hours, 6 hours, 1 days, 2 days, 3 days
Time Frame
up to 3 days after surgery
Title
Quality of life
Description
European organization for research and treatment of cancer (EORTC) and gastrointestinal quality of life index (GIQLI) questionnaire on postoperative 5 days, 1 month
Time Frame
up to 1 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyung-Ho Kim, M.D., Ph.D.
Organizational Affiliation
Department of Surgery, SNUBH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Geynggi
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30051365
Citation
Kang SH, Lee Y, Min SH, Park YS, Ahn SH, Park DJ, Kim HH. Multimodal Enhanced Recovery After Surgery (ERAS) Program is the Optimal Perioperative Care in Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Cancer: A Prospective, Randomized, Clinical Trial. Ann Surg Oncol. 2018 Oct;25(11):3231-3238. doi: 10.1245/s10434-018-6625-0. Epub 2018 Jul 26.
Results Reference
derived
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Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy
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