A RANDOMIZED, CONTROLLED, CLINICAL TRIAL TO COMPARE PERIPHERAL PARENTERAL NUTRITION (PeriOlimel N4-E) VS CONVENTIONAL FLUID THERAPY IN ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOL IN COLORECTAL CANCER SURGERY.

Phase 1

Conditions: Cancer colorectal
MedDRA version: 19.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-005325-39-ES

Lead Sponsor: Dr. Antonio Arroyo Sebastián

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Key Inclusion Criteria: age between 18-90 with scheduled colorectal cancer surgery and ASA I-IV.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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. Relative contraindications are: hemodynamic instability, acute pulmonary edema, hypotonic dehydration and/or decompensated heart failure.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;Secondary Objective: Not applicable;Primary end point(s): We set the primary endpoint as the presence of surgical postoperative complications during the first postoperative month.;Timepoint(s) of evaluation of this end point: 1 month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Among secondary endpoints of the study we will record during the first month postoperative clinical and demographic variables, ASA, clinical (medical) postoperative complications, length of stay, nutritional status and an economic evaluation through a cost-utility analysis, ;Timepoint(s) of evaluation of this end point: 1 month