Colon Cancer Clinical Trial
Official title:
A RANDOMIZED, CONTROLLED, CLINICAL TRIAL TO COMPARE PERIPHERAL PARENTERAL NUTRITION (PeriOlimel N4-E) VERSUS CONVENTIONAL FLUID THERAPY IN ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOL IN COLORECTAL CANCER SURGERY.
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 2019 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario de Elche | Elche | Alicante |
Lead Sponsor | Collaborator |
---|---|
Antonio Arroyo Sebastian |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | morbi-mortality | 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 | 30 days |
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