Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer

Study Overview
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Brief Summary
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At present, there are more and more reports about enhanced recovery after surgery（ERAS）in China, but there is no ERAS treatment standard for gastrointestinal cancer, and there are many factors limiting the development of ERAS. In recent years, due to the development of minimally invasive technology, the establishment of evidence-based medicine model and the development of MDT, it makes a good solid foundation for the clinical application of ERAS. The implementation of ERAS requires the cooperation of surgeons, anesthesia management, nursing, rehabilitation and other teams. As an individualized treatment mode, ERAS focuses on the optimization of treatment for different individuals in order to acquire the best benefit of patients. Therefore, the concept of ERAS is still in the process of continuous improvement and development in China, hoping to explore the Chinese ERAS clinical pathway for gastrointestinal cancer. The purpose of this study is to optimize the clinical pathway of ERAS in the perioperative period of gastrointestinal cancer, and to evaluate the effectiveness and safety of ERAS in gastrointestinal cancer.

Official Title
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A Single Center, Open, Randomized Clinical Trial：Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer

Conditions
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Enhanced Recovery After Surgery, Gastrointestinal Cancer

Intervention / Treatment
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* Procedure: Enhanced Recovery After Surgery （ERAS）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the informed consent Preoperative pathology confirmed gastric cancer or colorectal cancer Age: 18-70 years, men or women According to NCCN guidelines, it is not Stage IV tumor Perform radical gastrectomy or radical colon cancer surgery (CME) or radical rectal cancer surgery (TME); ASA I-III Receive no radiotherapy or chemotherapy before operation The subjects can describe the symptoms objectively and keep the follow-up plan Exclusion Criteria: Preoperative pathology confirmed no gastric cancer / no colorectal cancer (such as rectal neuroendocrine tumor, lymphoma, etc.) Stage IV or Radical resection can't be performed Emergency operation Can't cooperate with clinical data collection General condition is intolerable to operation Serious diseases, including heart function ≥ level II, respiratory function insufficiency, liver and kidney function insufficiency, and blood system diseases Patients participate in other clinical trials at the same time Pregnant or perinatal women Other malignant tumors History of mental illness Had a history of severe trauma within 4 weeks before admission Less than 6 months after other level 4 operations

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: ERAS<br>Perioperative intervention with individual Enhanced Recovery After Surgery （ERAS） | Procedure: Enhanced Recovery After Surgery （ERAS）<br>* Preoperative education，Preoperative nutritional support，Preoperative bowel preparation，Preventative applying of antibiotics，Intraoperative warming，Goal-directed fluid therapy，Postoperative analgesia，Postoperative diet, drainage and activity management，Prevention of deep vein thrombosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization Days |  | Postoperative up to 2 weeks | 
| Time of getting out of bed after operation |  | Postoperative 7 days | 
| The time to first flatus |  | Postoperative 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expenses on medical treatment, medicine and hospitalization |  | On discharge, Postoperative up to 2 weeks | 
| Incidence of postoperative complications |  | Postoperative 3 months、6 months、1 year |