IMMUNONUTRITION IN FAST-TRACK SURGERY

• Register: ClinicalTrials.gov
• Last refreshed on: 30 March 2015
• Main ID: NCT02393976
• Date of registration: 16/03/2015
• Prospective Registration: No
• Primary sponsor: Hospital General Universitario Elche
• Public title: IMMUNONUTRITION IN FAST-TRACK SURGERY
• Scientific title: NUTRITIONAL EFFECTS AND INFLUENCE IN THE MORBIDITY AND MORTALITY OF DIET IMMUNOMODULATORY IN FAST-TRACK SURGERY
• Date of first enrolment: January 2014
• Target sample size: 120
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02393976
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
• Phase: N/A

Countries of recruitment

Spain

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

IMMUNONUTRITION

Intervention(s)

Dietary Supplement: IMMUNONUTRITION

Dietary Supplement: STANDART NUTRITION

Primary Outcome(s)

Infectious complications [Time Frame: UP TO 30 DAYS POST-OPERATIVE]

Secondary ID(s)

Cirugía2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fundación Mutua Madrileña