Compliance to ERAS After Gastric Surgery

This study is currently recruiting participants.
Verified July 2012 by Chonnam National University Hospital
Sponsor:
Information provided by (Responsible Party):
Young Kyu Park, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01653496
First received: July 13, 2012
Last updated: July 27, 2012
Last verified: July 2012

July 13, 2012
July 27, 2012
July 2012
December 2013   (final data collection date for primary outcome measure)
Overall compliance to the ERAS program [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Patient's compliance to the 18 main elements of ERAS program
Same as current
Complete list of historical versions of study NCT01653496 on ClinicalTrials.gov Archive Site
  • Morbidity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    The length of hospital stay means the duration from the operation until hospital discharge.
  • Mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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%.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
173
April 2014
December 2013   (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
Both
18 Years to 70 Years
No
Contact: Young-Kyu Park, MD, PhD +82-61-379-7644 parkyk@jnu.ac.kr
Korea, Republic of
 
NCT01653496
CNUHGES-001
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
July 2012

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