Compliance to ERAS After Gastric Surgery (ERAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01653496
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : February 2, 2016
Information provided by (Responsible Party):
Young Kyu Park, Chonnam National University Hospital

July 13, 2012
July 31, 2012
February 2, 2016
July 2012
February 2014   (Final data collection date for primary outcome measure)
Overall compliance to the ERAS program [ Time Frame: 90 days ]
Patient's compliance to the 18 main elements of ERAS program
Same as current
Complete list of historical versions of study NCT01653496 on Archive Site
  • Morbidity [ Time Frame: 90 days ]
    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 [ Time Frame: 90 days ]
    The length of hospital stay means the duration from the operation until hospital discharge.
  • Mortality [ Time Frame: 90 days ]
    Any death related to surgery within 90 days after surgery
Same as current
Not Provided
Not Provided
Compliance to ERAS After Gastric Surgery
Phase II Study Evaluating the Compliance to the Enhanced Recovery After Surgery (ERAS) Program in Patients Undergoing Gastrectomy for Gastric Carcinoma
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.

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%.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stomach Neoplasms
Procedure: Enhanced recovery after surgery
The main 18 elements of ERAS program included are described in detail in the brief summary of the study
Experimental: Enhanced recovery after surgery
Patients who receive ERAS program after gastric cancer surgery
Intervention: Procedure: Enhanced recovery after surgery
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 May 22. doi: 10.1245/s10434-018-6524-4. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Plan to Share IPD: No
Young Kyu Park, Chonnam National University Hospital
Chonnam National University Hospital
Not Provided
Principal Investigator: Young-Kyu Park, MD, PhD Chonnam National University Hospital, Korea
Chonnam National University Hospital
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP