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

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.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Procedure: Enhanced recovery after surgery Phase 2

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%.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Compliance to the Enhanced Recovery After Surgery (ERAS) Program in Patients Undergoing Gastrectomy for Gastric Carcinoma
Study Start Date : July 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Enhanced recovery after surgery
Patients who receive ERAS program after gastric cancer surgery
Procedure: Enhanced recovery after surgery
The main 18 elements of ERAS program included are described in detail in the brief summary of the study

Primary Outcome Measures :
  1. Overall compliance to the ERAS program [ Time Frame: 90 days ]
    Patient's compliance to the 18 main elements of ERAS program

Secondary Outcome Measures :
  1. 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.

  2. Hospital stay [ Time Frame: 90 days ]
    The length of hospital stay means the duration from the operation until hospital discharge.

  3. Mortality [ Time Frame: 90 days ]
    Any death related to surgery within 90 days after surgery

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01653496

Korea, Republic of
Chonnam Nationl University Hwasun Hospital
Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809
Sponsors and Collaborators
Chonnam National University Hospital
Principal Investigator: Young-Kyu Park, MD, PhD Chonnam National University Hospital, Korea

Responsible Party: Young Kyu Park, Professor, Department of Gastroenterologic Surgery, Chonnam National University Hospital Identifier: NCT01653496     History of Changes
Other Study ID Numbers: CNUHGES-001
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Young Kyu Park, Chonnam National University Hospital:
Gastric cancer
Perioperative care
Enhanced recovery after surgery
Multimodal rehabilitation
Fast track surgery

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases