Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

IMMUNONUTRITION IN FAST-TRACK SURGERY

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02393976
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : March 20, 2015
Sponsor:
Collaborator:
Fundación Mutua Madrileña
Information provided by (Responsible Party):
Pedro Moya, Hospital General Universitario Elche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
IMMUNONUTRITION Dietary Supplement: IMMUNONUTRITION Dietary Supplement: STANDART NUTRITION Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: NUTRITIONAL EFFECTS AND INFLUENCE IN THE MORBIDITY AND MORTALITY OF DIET IMMUNOMODULATORY IN FAST-TRACK SURGERY
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Arm Intervention/treatment
CONTROL
STANDARD NUTRITION
Dietary Supplement: STANDART NUTRITION
STANDART NUTRITION PERIOPERATIVE

Experimental: IMMUNONUTRITION
INMUNONUTRITION
Dietary Supplement: IMMUNONUTRITION
IMMUNONUTRITION SUPLEMENTS PERIOPERATIVE




Primary Outcome Measures :
  1. Infectious complications [ Time Frame: UP TO 30 DAYS POST-OPERATIVE ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393976


Locations
Layout table for location information
Spain
Pedro Moya
Elche, Alicante, Spain, 03203
Sponsors and Collaborators
Hospital General Universitario Elche
Fundación Mutua Madrileña

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pedro Moya, PHD, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT02393976    
Other Study ID Numbers: Cirugía2
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015