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.
Overview
- Phase
- Phase 3
- Intervention
- Perioperative peripheral parenteral nutrition
- Conditions
- Colon Cancer
- Sponsor
- Antonio Arroyo Sebastian
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- morbi-mortality
- Last Updated
- 7 years ago
Overview
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.
Investigators
Antonio Arroyo Sebastian
Principal Investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Eligibility Criteria
Inclusion Criteria
- •scheduled colorectal cancer surgery
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
Arms & Interventions
Perioperative peripheral parenteral nutrition
Perioperative peripheral parenteral nutrition during 4 days
Intervention: Perioperative peripheral parenteral nutrition
Outcomes
Primary Outcomes
morbi-mortality
Time Frame: 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