IMMUNONUTRITION IN FAST-TRACK SURGERY

IMMUNONUTRITION Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393976
• Other study ID #: Cirugía2
• Status: Completed
• Phase: N/A
• First received: March 16, 2015
• Last updated: March 19, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• IMMUNONUTRITION

Intervention

Dietary Supplement:
• IMMUNONUTRITION
IMMUNONUTRITION SUPLEMENTS PERIOPERATIVE
• STANDART NUTRITION
STANDART NUTRITION PERIOPERATIVE

Locations

Country	Name	City	State
Spain	Pedro Moya	Elche	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General Universitario Elche	Fundación Mutua Madrileña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious complications		UP TO 30 DAYS POST-OPERATIVE	Yes