Compliance to ERAS After Gastric Surgery

NCT ID: NCT01653496

Last Updated: 2016-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-02-28

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.

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%.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enhanced recovery after surgery

Patients who receive ERAS program after gastric cancer surgery

Group Type: EXPERIMENTAL

Enhanced recovery after surgery

Intervention Type: PROCEDURE

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

Interventions

Enhanced recovery after surgery

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chonnam National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Young Kyu Park

Professor, Department of Gastroenterologic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young-Kyu Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital, Korea

Locations

Chonnam Nationl University Hwasun Hospital

Hwasun-gun, Jeollanam-do, South Korea

Countries

South Korea

References

Jung MR, Ryu SY, Park YK, Jeong O. Compliance with an Enhanced Recovery After a Surgery Program for Patients Undergoing Gastrectomy for Gastric Carcinoma: A Phase 2 Study. Ann Surg Oncol. 2018 Aug;25(8):2366-2373. doi: 10.1245/s10434-018-6524-4. Epub 2018 May 22.

Reference Type: DERIVED

PMID: 29789971 (View on PubMed)

Other Identifiers

CNUHGES-001

Identifier Type: -

Identifier Source: org_study_id