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| ID | Type | Description | Link |
|---|---|---|---|
| ISEEN | Registry Identifier | ISEEN |
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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard early enteral nutrition | Active Comparator | There would be 100 patients in this group |
|
| Immuno-enhanced early enteral nutrition | Experimental | There would 100 patients in this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immuno-enhanced | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to tolerate IEEN/SEEN | 30 days after operation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danhua Yao, MD/PhD | Contact | 8602580860961 | yaodh87@gmail.com | |
| Yousheng Li, MD/PhD | Contact | 8602580860137 | liys@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Danhua Yao, MD/PhD | Nanjing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital | Nanjing | Jiangsu | 210002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21628607 | Background | Osland E, Yunus RM, Khan S, Memon MA. Early versus traditional postoperative feeding in patients undergoing resectional gastrointestinal surgery: a meta-analysis. JPEN J Parenter Enteral Nutr. 2011 Jul;35(4):473-87. doi: 10.1177/0148607110385698. Epub 2011 May 31. | |
| 22788925 | Background | Liu H, Ling W, Shen ZY, Jin X, Cao H. Clinical application of immune-enhanced enteral nutrition in patients with advanced gastric cancer after total gastrectomy. J Dig Dis. 2012 Aug;13(8):401-6. doi: 10.1111/j.1751-2980.2012.00596.x. |
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| Standard early enteral nutrition | Drug | 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 |
|
| 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 |
| 21058198 | Background | Felekis D, Eleftheriadou A, Papadakos G, Bosinakou I, Ferekidou E, Kandiloros D, Katsaragakis S, Charalabopoulos K, Manolopoulos L. Effect of perioperative immuno-enhanced enteral nutrition on inflammatory response, nutritional status, and outcomes in head and neck cancer patients undergoing major surgery. Nutr Cancer. 2010;62(8):1105-12. doi: 10.1080/01635581.2010.494336. |