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The aim of this study is to find which is the best nutritional strategy in cancer patients undergoing abdominal surgery regarding postoperative complications.
There is a controversy regarding the timing of initiation of parenteral nutrition in cancer patients undergoing abdominal surgery in whom caloric targets cannot be met by enteral nutrition alone.
This is a randomized and controlled trial comparing early initiation with late initiation of parenteral nutrition.
Early-initiation group: patients will be randomized to initiate parenteral nutrition in the 2nd day after surgery.
Late-initiation group: patients will be randomized to initiate parenteral nutrition in the 7th day after surgery.
Calculations regarding the caloric goal included protein energy and were based on corrected ideal body weight, age and sex. When oral or enteral nutrition covered 80% of the calculated caloric goal, parenteral nutrition was reduced and progressively stopped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early parenteral nutrition | Active Comparator | Parenteral nutrition starts at 2nd postoperative day. |
|
| Late parenteral nutrition | Active Comparator | Parenteral nutrition starts at 7th postoperative day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early parenteral nutrition | Dietary Supplement |
| ||
| Late parenteral nutrition |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical complications | respiratory, cardiovascular, renal, neurological, infectious, surgical | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 30-day mortality | 30 days |
| Length of stay in ICU and in hospital | Length of stay | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Marques, MD | Instituto do Cancer do Estado de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute of the State of Sao Paulo | São Paulo | São Paulo | 01246-000 | Brazil | ||
| ICESP |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Dietary Supplement |
|
| ICU readmission rate | ICU readmission rate | 30 days |
| Duration of pharmacologic hemodynamic support | duration of vasopressor therapy | 30 days |
| Levels of C-reactive protein | serum levels of C-reactive protein | 7 days |
| Duration of mechanical ventilation | Duration of invasive mechanical ventilation | 30 days |
| Liver dysfunction | liver dysfunction according SOFA | 30 days |
| São Paulo |
| São Paulo |
| 01414001 |
| Brazil |