ERAS for Patients Received Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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Patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the enhanced recovery after surgery (ERAS) programs or the standard cares (SC) programs.

Detailed Description
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Before, most trials about the ERAS for radical gastrectomy demonstrated ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing postoperative complications. However, in most trials, patients who received neoadjuvant chemotherapy were excluded. The investigators designed this trial for patients received neoadjuvant chemotherapy. In this trial, patients received neoadjuvant chemotherapy with locally advanced gastric caner undergo the ERAS programs or the SC programs. Finally, the investigators evaluated whether patients who receive neoadjuvant chemotherapy can be enrolled into the ERAS programs for locally advanced gastric cancer.

Official Title
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Enhanced Recovery After Surgery Programs for Patients Received Neoadjuvant Chemotherapy With Locally Advanced Gastric Cancer: a Randomized Controlled Clinical Trial

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: ERAS group
* Procedure: SC group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients received neoadjuvant chemotherapy with locally advanced gastric cancer. Age older than 18 and younger than 75 years. American Society of Anesthesiologists (ASA) class: I-III. Participants can describe the symptom objectively and cooperate actively. Written informed consent. Exclusion Criteria: Patients allergic to oxaliplatin, tegafur gimerac etc. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA) Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer. Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min). Patients who require simultaneous surgery for other diseases. Patients who received upper abdominal surgery previously. Pregnant or breast-feeding women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a parallel, open-label randomized controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>Patients will undergo the ERAS programs. | Procedure: ERAS group<br>* ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.<br>|
| Other: SC group<br>Patients will undergo the SC group. | Procedure: SC group<br>* Patients were managed in accordance with SC programs during the perioperative period. SC programs were used daily in our center and were still routinely used in most of the other hospitals in China.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of stay | Postoperative length of stay | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications | 2 months | 
| The time to first flatus | Bowel recovery | 1 week | 
| Time to semi-liquid diet | Bowel recovery | 2 week |