Gastrointestinal Postoperative Early Enteral Nutrition: Immuno-enhanced Versus Standard Early Enteral Nutrition

Study Overview
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Brief Summary
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Patients with gastrointestinal(GI) malignancy usually suffer from malnutrition and suppressed immune function, which might be worsened by major elective surgery.Enteral nutrition has been emphasized for patients with GI malignancy during the perioperative period to accelerate bowel function recovery, and improve nitrogen balance and immune response while reducing postoperative complications and hospitalization time.Early enteral nutrition(EEN) can promote the postoperative recovery of GI function and has been considered to have other advantages such as the reduction of medical cost and maintenance of intestinal barrier function. Immunonutrition containing special compounds like omega-3-unsaturated fatty acids has been put forward to modulate the immune response and improve the immune function in patients with cancer, which may have an better effect on the immune system than standard enteral nutrition. However, studies on immuno-enhanced early enteral nutrition after a resectable GI malignancy surgery are scarce. The aim of this study was to determine whether immuno-enhanced early enteral nutrition(IEEN) is more effective than standard early enteral nutrition(SEEN) on nutritional status, immune function, surgical outcomes,time to adjuvant chemotherapy and days of hospitalization after laparoscopic GI surgery.

Official Title
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Immuno-enhanced Versus Standard Early Enteral Nutrition Use in Gastrointestinal Postoperative Patients

Conditions
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Gastrointestinal Malignant

Intervention / Treatment
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* Drug: Immuno-enhanced
* Drug: Standard early enteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resectable gastric cancer by laparoscope Resectable colorectal cancer laparoscope Resectable gastrointestinal interstitialoma by laparoscope Exclusion Criteria: Locally unresectable tumor Metastatic tumor Preoperative total parenteral or enteral nutrition Lack of the patient's consent for the trial participation Previous gastrointestinal resection

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard early enteral nutrition<br>There would be 100 patients in this group | Drug: Standard early enteral nutrition<br>* Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C standard enteral nutrition fluid 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube<br>|
| Experimental: Immuno-enhanced early enteral nutrition<br>There would 100 patients in this group | Drug: Immuno-enhanced<br>* Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C enteral nutrition fluid concerning omega-3-unsaturated fatty acids 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tolerate IEEN/SEEN |  | 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall morbidity rate of IEEN/SEEN |  | 60 days after operation | 
| Mortality rate of IEEN/SEEN after operation |  | 60 days after operation | 
| Energy metabolism |  | 10 days after operation | 
| Time to the first postoperative adjuvant chemotherapy |  | 30 days after operation | 
| Nutritional status in postoperative day1and 7 of IEEN/SEEN |  | 7 days after operation | 
| Immune function in postoperative day 1 and 7 |  | 7 days after operation | 
| Postoperative hospital stay length |  | 60 days after operation | 
| Rehospitalization rate |  | 30 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early enteral nutrition, Laparoscopic gastrointestinal surgery, Immuno-enhanced nutrition