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Clinical Trials/NCT02393976
NCT02393976CompletedNot Applicable

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

Hospital General Universitario Elche2 sites in 1 country120 target enrollmentStarted: January 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
120
Locations
2
Primary Endpoint
Infectious complications

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • Pregnant or breastfeeding
  • intestinal obstruction
  • uncontrolled infection
  • No acceptance or failure to follow protocol multimodal rehabilitation.

Outcomes

Primary Outcomes

Infectious complications

Time Frame: UP TO 30 DAYS POST-OPERATIVE

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hospital General Universitario Elche
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pedro Moya

PHD

Hospital General Universitario Elche

Study Sites (2)

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