IMMUNONUTRITION IN FAST-TRACK SURGERY

March 19, 2015 updated by: Pedro Moya, Hospital General Universitario Elche

NUTRITIONAL EFFECTS AND INFLUENCE IN THE MORBIDITY AND MORTALITY OF DIET IMMUNOMODULATORY IN FAST-TRACK SURGERY

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Pedro Moya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CONTROL
STANDARD NUTRITION
Dietary supplement: STANDART NUTRITION
STANDART NUTRITION PERIOPERATIVE
Experimental: IMMUNONUTRITION
INMUNONUTRITION
Dietary supplement: IMMUNONUTRITION
IMMUNONUTRITION SUPLEMENTS PERIOPERATIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infectious complications
Time Frame: UP TO 30 DAYS POST-OPERATIVE
UP TO 30 DAYS POST-OPERATIVE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Elche

Collaborators

Fundación Mutua Madrileña

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Cirugía2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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