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Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery

Not Applicable
Conditions
Abdominal Surgery
Parenteral Nutrition
Cancer
Interventions
Dietary Supplement: Late parenteral nutrition
Dietary 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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Late parenteral nutritionLate parenteral nutritionParenteral nutrition starts at 7th postoperative day.
Early parenteral nutritionEarly parenteral nutritionParenteral nutrition starts at 2nd postoperative day.
Primary Outcome Measures
NameTimeMethod
Clinical complications30 days

respiratory, cardiovascular, renal, neurological, infectious, surgical

Secondary Outcome Measures
NameTimeMethod
Mortality30 days

30-day mortality

Duration of pharmacologic hemodynamic support30 days

duration of vasopressor therapy

Length of stay in ICU and in hospital30 days

Length of stay

ICU readmission rate30 days

ICU readmission rate

Levels of C-reactive protein7 days

serum levels of C-reactive protein

Duration of mechanical ventilation30 days

Duration of invasive mechanical ventilation

Liver dysfunction30 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

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