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Clinical Trials/EUCTR2015-005325-39-ES
EUCTR2015-005325-39-ES
Active, not recruiting
Phase 1

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.

Dr. Antonio Arroyo Sebastián0 sitesMay 17, 2016
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ConditionsCancer colorectalMedDRA 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]
DrugsPERIOLIMEL N4E, emulsion for infusion

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cancer colorectal
Sponsor
Dr. Antonio Arroyo Sebastián
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 17, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dr. Antonio Arroyo Sebastián

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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