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Clinical Trials/NCT00559520
NCT00559520
Completed
Phase 4

The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

Centre Hospitalier Universitaire de Nice1 site in 1 country250 target enrollmentFebruary 2002
ConditionsUndernutrition

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Undernutrition
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
250
Locations
1
Primary Endpoint
Weight
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The role of preoperative oral immunonutrition in major vascular surgery.

The mean purpose of this study was to determine the prevalence of post-operative infection complications after major vascular surgery in group of patients with preoperative oral immunonutrition.

This group was compared to a control group.

Secondary purpose was to evaluate the effect of preoperative oral immunonutrition on postoperative mortality (30 days), the medium length of stay in the hospital and the cost of treatment in the two groups

Registry
clinicaltrials.gov
Start Date
February 2002
End Date
December 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Intervention planned since at least 5 days before surgery
  • Duration of hospitalization of at least 5 days

Exclusion Criteria

  • Pregnant or lactating woman
  • Patient with severe renal insufficiency
  • Patient under 18 years old
  • Patient infected with HIV,hépatitis B or C

Outcomes

Primary Outcomes

Weight

Time Frame: before surgery, five days and thirty days after surgery

Arisen of an infectious complication

Time Frame: during the period of 30 days following the surgery

Arisen of non infectious complication

Time Frame: during the period of 30 days following the surgery

Secondary Outcomes

  • Primary and secondary permeability(at 5 and 30 days after surgery)
  • Pain(at 5 and 30 days after surgery)
  • Healing(at 5 and 30 days after surgery)

Study Sites (1)

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