Cancer colorectal MedDRA version: 19.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: PERIOLIMEL N4E, emulsion for infusion
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: REFINED OLIVE OIL AND REFINED SOYA OIL
Other descriptive name: REFINED OLIVE OIL AND R
Sponsors
Dr. Antonio Arroyo Sebastián
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactDr. Antonio Arroyo Sebastián
Dr. Antonio Arroyo Sebastián
Outcome results
None listed