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Phase II Study Evaluating the Compliance to the Enhanced Recovery After Surgery (ERAS) Program in Patients Undergoing Gastrectomy for Gastric Carcinoma

Phase 2
18 Years
70 Years
Open (Enrolling)
Stomach Neoplasms

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Trial Information

Phase II Study Evaluating the Compliance to the Enhanced Recovery After Surgery (ERAS) Program in Patients Undergoing Gastrectomy for Gastric Carcinoma

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%.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall compliance to the ERAS program

Outcome Description:

Patient's compliance to the 18 main elements of ERAS program

Outcome Time Frame:

90 days

Safety Issue:


Principal Investigator

Young-Kyu Park, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chonnam National University Hospital, Korea


Korea: Institutional Review Board

Study ID:




Start Date:

July 2012

Completion Date:

April 2014

Related Keywords:

  • Stomach Neoplasms
  • Gastric cancer
  • Perioperative care
  • Enhanced recovery after surgery
  • Multimodal rehabilitation
  • Fast track surgery
  • Gastrectomy
  • Neoplasms
  • Stomach Neoplasms