Compliance to ERAS After Gastric Surgery (ERAS)
Primary Purpose
Stomach Neoplasms
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Enhanced recovery after surgery
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Gastric cancer, Perioperative care, Enhanced recovery after surgery, Multimodal rehabilitation, Fast track surgery, Gastrectomy
Eligibility Criteria
Inclusion Criteria:
- Patients who are to undergo gastric cancer surgery
- ASA score < 3
- ECOG performance status 0-1
- Adequate hepatic, renal, and hematologic function
- Written informed consent
Exclusion Criteria:
- Previous abdominal operation history
- Concommitant other organ malignant disease
- Preoperative chemotherapy or radiation therapy
- Concommitant other organ resection during surgery
- Emergency operation due to bleeding or perforation
- Active underlying medical illness
- Pregnancy
Sites / Locations
- Chonnam Nationl University Hwasun Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enhanced recovery after surgery
Arm Description
Patients who receive ERAS program after gastric cancer surgery
Outcomes
Primary Outcome Measures
Overall compliance to the ERAS program
Patient's compliance to the 18 main elements of ERAS program
Secondary Outcome Measures
Morbidity
Postoperative complications means any complications occured within 90 days after operation, and will be assessed based on the predefined definition and severity of postoperative complication of our institution.
Hospital stay
The length of hospital stay means the duration from the operation until hospital discharge.
Mortality
Any death related to surgery within 90 days after surgery
Full Information
NCT ID
NCT01653496
First Posted
July 13, 2012
Last Updated
February 1, 2016
Sponsor
Chonnam National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01653496
Brief Title
Compliance to ERAS After Gastric Surgery
Acronym
ERAS
Official Title
Phase II Study Evaluating the Compliance to the Enhanced Recovery After Surgery (ERAS) Program in Patients Undergoing Gastrectomy for Gastric Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to prospectively evaluate the overall compliance to the enhanced recovery after surgery (ERAS) program in patients undergoing gastric cancer surgery.
Detailed Description
The feasibility and effectiveness of ERAS program for various major surgical procedures have been well studies in the literature. However, ERAS program has not been widely accepted for patients undergoing gastric cancer surgery because of the paucity of evidence about its feasibility and efficacy. In this study, we developed ERAS program for gastric cancer surgery, based on the systemic review about perioperative cares. The main elements of ERAS program includes: 1preoperative patient education, 2)no preoperative bowel preparation, 3) provision of normal diet until the night before surgery, 4)carbohydrate rich drink 2 hrs before surgery, 5)epidural anesthesia for pain control, 6) local wound anesthetic infiltration for pain control, 7)no routine abdominal drain, 8)no naso-gastric tube insertion, 9)intraoperative antibiotics, 10)thromboprophylaxis using intermittent pneumatic compression device, 11)intraoperative normothermia using warm air blanket, 12)low oxygen supply during immediate postoperative period, 13)restrictive postoperative fluid administration, 14)early postoperative oral diet, 15)early active ambulation, 16)early removal of the urinary catheter, 17)patient education before discharge, and 18)hospital discharge based on discharge criteria.
The aim of study is to evaluate the compliance to these main elements of ERAS program in patients undergoing gastric cancer surgery.
Previously reported data about ERAS program for colon surgery reported overall compliance as about 65%. Considering that this is a single center study, we expected overall compliance rate of 70%. Therefore, the sample size of 173 patients was calculated based on this expected compliance rate, with permitted error of 95% confidence interval of 14%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Gastric cancer, Perioperative care, Enhanced recovery after surgery, Multimodal rehabilitation, Fast track surgery, Gastrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced recovery after surgery
Arm Type
Experimental
Arm Description
Patients who receive ERAS program after gastric cancer surgery
Intervention Type
Procedure
Intervention Name(s)
Enhanced recovery after surgery
Intervention Description
The main 18 elements of ERAS program included are described in detail in the brief summary of the study
Primary Outcome Measure Information:
Title
Overall compliance to the ERAS program
Description
Patient's compliance to the 18 main elements of ERAS program
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Morbidity
Description
Postoperative complications means any complications occured within 90 days after operation, and will be assessed based on the predefined definition and severity of postoperative complication of our institution.
Time Frame
90 days
Title
Hospital stay
Description
The length of hospital stay means the duration from the operation until hospital discharge.
Time Frame
90 days
Title
Mortality
Description
Any death related to surgery within 90 days after surgery
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are to undergo gastric cancer surgery
ASA score < 3
ECOG performance status 0-1
Adequate hepatic, renal, and hematologic function
Written informed consent
Exclusion Criteria:
Previous abdominal operation history
Concommitant other organ malignant disease
Preoperative chemotherapy or radiation therapy
Concommitant other organ resection during surgery
Emergency operation due to bleeding or perforation
Active underlying medical illness
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Kyu Park, MD, PhD
Organizational Affiliation
Chonnam National University Hospital, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam Nationl University Hwasun Hospital
City
Hwasun-gun
State/Province
Jeollanam-do
ZIP/Postal Code
519-809
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29789971
Citation
Jung MR, Ryu SY, Park YK, Jeong O. Compliance with an Enhanced Recovery After a Surgery Program for Patients Undergoing Gastrectomy for Gastric Carcinoma: A Phase 2 Study. Ann Surg Oncol. 2018 Aug;25(8):2366-2373. doi: 10.1245/s10434-018-6524-4. Epub 2018 May 22.
Results Reference
derived
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Compliance to ERAS After Gastric Surgery
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