Abdominal Surgery, Cancer, Parenteral Nutrition
Conditions
Keywords
parenteral nutrition, early nutrition, abdominal surgery, cancer
Brief summary
The aim of this study is to find which is the best nutritional strategy in cancer patients undergoing abdominal surgery regarding postoperative complications.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTEarly parenteral nutrition
DIETARY_SUPPLEMENTLate parenteral nutrition
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older than 18 years * Laparotomy for abdominal cancer surgery: urological, gynecological, digestive, abdominal sarcomas and melanomas, lymphomas and abdominal vascular. * Informed consent form signed by the patient or legal guardian.
Exclusion criteria
* Reoperation within one year from the previous surgery. using previously parenteral nutrition. * Participation in another research protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical complications | 30 days | respiratory, cardiovascular, renal, neurological, infectious, surgical |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in ICU and in hospital | 30 days | Length of stay |
| ICU readmission rate | 30 days | ICU readmission rate |
| Duration of pharmacologic hemodynamic support | 30 days | duration of vasopressor therapy |
| Mortality | 30 days | 30-day mortality |
| Duration of mechanical ventilation | 30 days | Duration of invasive mechanical ventilation |
| Liver dysfunction | 30 days | liver dysfunction according SOFA |
| Levels of C-reactive protein | 7 days | serum levels of C-reactive protein |
Countries
Brazil
Outcome results
None listed