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Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS

NCT ID: NCT03606863

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Colon Cancer Parenteral Nutrition Fast-track

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Perioperative peripheral parenteral nutrition

Perioperative peripheral parenteral nutrition during 4 days

Group Type EXPERIMENTAL

Perioperative peripheral parenteral nutrition

Intervention Type DRUG

Standard fluid therapy

Standard fluid therap

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Perioperative peripheral parenteral nutrition

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antonio Arroyo Sebastian

OTHER

Sponsor Role lead

Responsible Party

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Antonio Arroyo Sebastian

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Antonio Arroyo, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad Valenciana

Locations

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Hospital General Universitario de Elche

Elche, Alicante, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Antonio Arroyo, MD

Role: CONTACT

Phone: 966 616 000

Email: [email protected]

Facility Contacts

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ANTONIO ARROYO, MD

Role: primary

Other Identifiers

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ELX-NPP-2016-01

Identifier Type: -

Identifier Source: org_study_id