Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery
- Conditions
- Abdominal SurgeryParenteral NutritionCancer
- Interventions
- Dietary Supplement: Late parenteral nutritionDietary Supplement: Early parenteral nutrition
- Registration Number
- NCT01839617
- Lead Sponsor
- Instituto do Cancer do Estado de São Paulo
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 335
- 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.
- Reoperation within one year from the previous surgery. using previously parenteral nutrition.
- Participation in another research protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Late parenteral nutrition Late parenteral nutrition Parenteral nutrition starts at 7th postoperative day. Early parenteral nutrition Early parenteral nutrition Parenteral nutrition starts at 2nd postoperative day.
- Primary Outcome Measures
Name Time Method Clinical complications 30 days respiratory, cardiovascular, renal, neurological, infectious, surgical
- Secondary Outcome Measures
Name Time Method Mortality 30 days 30-day mortality
Duration of pharmacologic hemodynamic support 30 days duration of vasopressor therapy
Length of stay in ICU and in hospital 30 days Length of stay
ICU readmission rate 30 days ICU readmission rate
Levels of C-reactive protein 7 days serum levels of C-reactive protein
Duration of mechanical ventilation 30 days Duration of invasive mechanical ventilation
Liver dysfunction 30 days liver dysfunction according SOFA
Trial Locations
- Locations (2)
Cancer Institute of the State of Sao Paulo
🇧🇷São Paulo, SP, Brazil
ICESP
🇧🇷Sao Paulo, SP, Brazil