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The aim of this study is to analyze the effect of enriched formula with omega-3 in the 30-day incidence infection and inflammatory response following lung resection surgery in lung cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental enteral nutrition | Experimental | Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer enriched enteral formula |
|
| Experimental oral nutrition | Experimental | Patients admitted one day before surgery. Home-self administration of enriched enteral formula three days before surgery |
|
| Standard enteral nutrition | Other | Patients admitted to the hospital at least three days before surgery Use of an enteral feeding tube to administer standard enteral formula |
|
| Standard oral nutrition | Other | Patients admitted one day before surgery. Home-self administration of standard enteral formula three days before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish oil enteral supplementation | Dietary Supplement | Omega-3 (4.2 g), administered through an enteral feeding tube, three days before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day incidence infection | Incidence of infectious complications after surgery diagnosed using any of these criteria: Infection of surgery wound confirmed by culture Infection confirmed by blood culture Pneumonia developed after surgery confirmed by chest x Ray. | 30-day incidence infection following lung resection in lung cancer patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in prostaglandin E2 | Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA). | At the beginning of nutritional therapy and at day-4 following surgery |
| Changes in Interleukin-6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivan A Osuna-Padilla, PhD | Contact | 5487-1700 | 5059 | ivan.osuna@iner.gob.mx |
| Ana L Gómez-Rodriguez, MSc | Contact | 5487-1700 | 5059 | grolucia@yahoo.es |
| Name | Affiliation | Role |
|---|---|---|
| Ivan A Osuna-Padilla, PhD | Instituto Nacional de Enfermedades Respiratorias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Respiratory Diseases | Recruiting | Mexico City | 14080 | Mexico |
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Randomized Clinical Trial
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Use of enteral formula enriched with omega-3 or standard not revealed for participants.
| Fish oil oral supplementation | Dietary Supplement | Omega-3 (4.2 g), orally administered enriched nutritional formula, drinking at home three days before surgery |
|
| Enteral nutrition without fish oil | Dietary Supplement | Enteral formula without omega-3 administered through an enteral feeding tube, three days before surgery |
|
| Oral nutritional supplement without fish oil | Dietary Supplement | Oral nutritional supplement without omega-3 orally administered, drinking at home three days before surgery |
|
Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA).
| At the beginning of nutritional therapy and at day-4 following surgery |
| Changes in Tumor Necrosis Factor Alpha (TNF-α) | Measured in serum sample made by Enzyme-linked immunosorbent assay (ELISA). | At the beginning of nutritional therapy and at day-4 following surgery |
| Number of participants with therapeutic antibiotics prescription | Frequency of therapeutic antibiotics prescription will be collected from medical records and medication administration registers. | During the hospital stay until 30-day |
| Hospital lenght of stay | Number of calendar days that elapsed since hospital admission to the day of hospital discharge | During the hospital stay until 90-day |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D007239 | Infections |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| D005395 | Fish Oils |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
| D009821 | Oils |
| D008055 | Lipids |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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