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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Versus Late Parenteral Nutrition in Cancer Patients Undergoing Abdominal Surgery

Conditions
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Cancer, Abdominal Surgery, Parenteral Nutrition

Intervention / Treatment
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* Dietary Supplement: Early parenteral nutrition
* Dietary Supplement: Late parenteral nutrition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early parenteral nutrition<br>Parenteral nutrition starts at 2nd postoperative day. | Dietary Supplement: Early parenteral nutrition<br> <br> |
| Active Comparator: Late parenteral nutrition<br>Parenteral nutrition starts at 7th postoperative day. | Dietary Supplement: Late parenteral nutrition<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical complications | respiratory, cardiovascular, renal, neurological, infectious, surgical | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | 30-day mortality | 30 days | 
| Length of stay in ICU and in hospital | Length of stay | 30 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, parenteral nutrition, early nutrition, abdominal surgery