Postoperative Enteral Immunonutrition in Gastric Cancer

Study Overview
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Brief Summary
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Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival. The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients. The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

Detailed Description
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Treatment of gastric cancer often requires major surgery and carries the risk of postoperative complications and fatal outcomes. Mortality rates after gastrectomy due to gastric cancer have been reported as 2-5%, while the incidence of postoperative complications was 10 to over 40%. Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival. The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients. The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 or standard enteral nutrition n=54. Following the initial randomization, the patients received either standard nutrition (oligopeptide, low-fat, isocaloric, non-residue diet - Peptisorb, Nutricia) or immunomodulating nutrition (protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

Official Title
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The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients

Conditions
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Gastric Cancer

Intervention / Treatment
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* Dietary Supplement: Immunomodulating nutrition (Reconvan)
* Dietary Supplement: Standard nutrition (Peptisorb)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gastric cancer confirmed in histopathological examination elective operation due to gastric cancer informed consent signed age > 18 years normal nutritional status or mild to moderate malnutrition Exclusion Criteria: severe malnutrition which required parenteral nutrition urgent operation

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Immunomodulating nutrition (Reconvan) | Dietary Supplement: Immunomodulating nutrition (Reconvan)<br>* protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi<br>|
| Active Comparator: Control group<br>Standard nutrition (Peptisorb) | Dietary Supplement: Standard nutrition (Peptisorb)<br>* oligopeptide, low-fat, isocaloric, non-residue diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication rate | Complication rate during 30 days after the operation | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 5-year overall survival | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunonutrition, gastric cancer, enteral nutrition