Compliance to ERAS After Gastric Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Chonnam National University Hospital.
Recruitment status was  Recruiting
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
  Purpose

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 Intervention Phase
Stomach Neoplasms
Procedure: Enhanced recovery after surgery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 173
Study Start Date: July 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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%.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653496

Contacts
Contact: Young-Kyu Park, MD, PhD +82-61-379-7644 parkyk@jnu.ac.kr

Locations
Korea, Republic of
Chonnam Nationl University Hwasun Hospital Recruiting
Hwasun-gun, Jeollanam-do, Korea, Republic of, 519-809
Contact: Oh Jeong, MD    +82-10-9696-3699    surgeonjeong@yahoo.co.kr   
Principal Investigator: Young-Kyu Park, MD, PhD         
Sponsors and Collaborators
Chonnam National University Hospital
Investigators
Principal Investigator: Young-Kyu Park, MD, PhD Chonnam National University Hospital, Korea
  More Information

No publications provided

Responsible Party: Young Kyu Park, Professor, Department of Gastroenterologic Surgery, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01653496     History of Changes
Other Study ID Numbers: CNUHGES-001
Study First Received: July 13, 2012
Last Updated: July 27, 2012
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 28, 2014