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Completed

NCT Number: NCT01653496

Compliance to ERAS After Gastric Surgery

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonnam Nationl University Hwasun Hospital

Hwasun-gun, Jeollanam-do, 519-809, South Korea

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced recovery after surgery

Procedure

The main 18 elements of ERAS program included are described in detail in the brief summary of the study

Primary outcomes

  1. Overall compliance to the ERAS program

    Time frame: 90 days

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Registry information

Official study title

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

Acronym: ERAS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 31, 2012
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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