Colon Cancer, Fast-track, Parenteral Nutrition
Conditions
Brief summary
Assess if administration of early nutrition support with Perioperative Peripheral Nutrition (PeriOliclimonel) N4-E) in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery (ERAS) Protocol improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy.
Detailed description
The main objective is to determine if perioperative nutritional support with PeriOlimel N4-E, that reaches nutritional requirements of ERAS protocol for colorectal cancer surgery patients, can improve nutritional status so it decreases postoperative complications, hospital length of stay and costs, compared to conventional fluid therapy administration since patients receive oral nutrition at day 3-5.
Interventions
DRUGPerioperative peripheral parenteral nutrition
Sponsors
Antonio Arroyo Sebastian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* scheduled colorectal cancer surgery * ASA I-IV
Exclusion criteria
* Emergency surgery * Distant metastasis * Patient´s refusal to participate * Allergy or hypersensitivity to egg or soy protein * Advanced kidney or hepatic impairment * Severe bleeding disorders * Congenital abnormalities of amino acid metabolism * Hyperlipidemia and severe or difficult to control hyperglycemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| morbi-mortality | 30 days | Early Peripheral Parenteral Nutrition in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery Protocol to improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy |
Countries
Spain
Contacts
Primary ContactAntonio Arroyo, MD
Outcome results
None listed