Compliance to ERAS After Gastric Surgery

Stomach Neoplasms Clinical Trial

— ERAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653496
• Other study ID #: CNUHGES-001
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2012
• Last updated: February 1, 2016
• Start date: July 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2016
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• Enhanced recovery after surgery
The main 18 elements of ERAS program included are described in detail in the brief summary of the study

Locations

Country	Name	City	State
Korea, Republic of	Chonnam Nationl University Hwasun Hospital	Hwasun-gun	Jeollanam-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall compliance to the ERAS program	Patient's compliance to the 18 main elements of ERAS program	90 days	Yes
Secondary	Morbidity	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.	90 days	Yes
Secondary	Hospital stay	The length of hospital stay means the duration from the operation until hospital discharge.	90 days	No
Secondary	Mortality	Any death related to surgery within 90 days after surgery	90 days	Yes