Compliance to ERAS After Gastric Surgery

Study Overview
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Brief Summary
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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
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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%.

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

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Procedure: Enhanced recovery after surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced recovery after surgery<br>Patients who receive ERAS program after gastric cancer surgery | Procedure: Enhanced recovery after surgery<br>* The main 18 elements of ERAS program included are described in detail in the brief summary of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall compliance to the ERAS program | Patient's compliance to the 18 main elements of ERAS program | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Hospital stay | The length of hospital stay means the duration from the operation until hospital discharge. | 90 days | 
| Mortality | Any death related to surgery within 90 days after surgery | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Perioperative care, Enhanced recovery after surgery, Multimodal rehabilitation, Fast track surgery, Gastrectomy