Compliance to ERAS After Gastric Surgery
Conditions
Stomach Neoplasms
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric cancer, Perioperative care, Enhanced recovery after surgery, Multimodal rehabilitation, Fast track surgery, Gastrectomy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Enhanced recovery after surgery
Type: Procedure
Overall Status
Recruiting
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%.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Chonnam Nationl University Hwasun Hospital
Hwasun-gun, Jeollanam-do, Korea, Republic of
Status: Recruiting
Contact: Oh Jeong, MD - +82-10-9696-3699 - surgeonjeong@yahoo.co.kr
Start Date
July 2012
Completion Date
April 2014
Sponsors
Chonnam National University Hospital
Source
Chonnam National University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page