IMMUNONUTRITION IN FAST-TRACK SURGERY

NCT ID: NCT02393976

Last Updated: 2015-03-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

Brief Summary

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Compare the results in terms of morbidity, mortality and hospitalization among patients with input from immunonutrients and patients with enteral nutrition intake of high calorie and high protein undergoing colorectal surgery within a multimodal rehabilitation program.

Detailed Description

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Conditions

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IMMUNONUTRITION

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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CONTROL

STANDARD NUTRITION

Group Type OTHER

STANDART NUTRITION

Intervention Type DIETARY_SUPPLEMENT

STANDART NUTRITION PERIOPERATIVE

IMMUNONUTRITION

INMUNONUTRITION

Group Type EXPERIMENTAL

IMMUNONUTRITION

Intervention Type DIETARY_SUPPLEMENT

IMMUNONUTRITION SUPLEMENTS PERIOPERATIVE

Interventions

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IMMUNONUTRITION

IMMUNONUTRITION SUPLEMENTS PERIOPERATIVE

Intervention Type DIETARY_SUPPLEMENT

STANDART NUTRITION

STANDART NUTRITION PERIOPERATIVE

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing colorectal surgery.
* Signing informed consent.

Exclusion Criteria

* Patients with no oral nutrition (dysphagia, esophageal stricture, pyloric stenosis)
* Patients with contraindications for electrical stimulation.
* Psychiatric Disorders
* HIV
* Pregnant or breastfeeding
* intestinal obstruction
* uncontrolled infection
* ASA IV
* No acceptance or failure to follow protocol multimodal rehabilitation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Mutua Madrileña

OTHER

Sponsor Role collaborator

Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Pedro Moya

PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pedro Moya

Elche, Alicante, Spain

Site Status

Countries

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Spain

References

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Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.

Reference Type DERIVED
PMID: 27227930 (View on PubMed)

Other Identifiers

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Cirugía2

Identifier Type: -

Identifier Source: org_study_id

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