Compliance to ERAS After Gastric Surgery

Chonnam National University

Status and phase: Completed; Phase 2

Conditions: Stomach Neoplasms

Treatments: Procedure: Enhanced recovery after surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01653496

CNUHGES-001

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 168 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 1 patient group

Enhanced recovery after surgery

Experimental group

Description:

Patients who receive ERAS program after gastric cancer surgery

Treatment:

Procedure: Enhanced recovery after surgery