IMMUNONUTRITION Clinical Trial
Official title:
NUTRITIONAL EFFECTS AND INFLUENCE IN THE MORBIDITY AND MORTALITY OF DIET IMMUNOMODULATORY IN FAST-TRACK SURGERY
Verified date | March 2015 |
Source | Hospital General Universitario Elche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Spain | Pedro Moya | Elche | Alicante |
Lead Sponsor | Collaborator |
---|---|
Hospital General Universitario Elche | Fundación Mutua Madrileña |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infectious complications | UP TO 30 DAYS POST-OPERATIVE | Yes |
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