Clinical trial NCT00559520: The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery
Official title: The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Undernutrition
Keywords: Patients
Suffering
Undernutrition
Requiring
Vascular
Surgery
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2007-11-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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


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

Primary outcomes:
measure: Weight
timeFrame: before surgery, five days and thirty days after surgery
measure: Arisen of an infectious complication
timeFrame: during the period of 30 days following the surgery
measure: Arisen of non infectious complication
timeFrame: during the period of 30 days following the surgery
Secondary outcomes:
measure: Primary and secondary permeability
timeFrame: at 5 and 30 days after surgery
measure: Pain
timeFrame: at 5 and 30 days after surgery
measure: Healing
timeFrame: at 5 and 30 days after surgery
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE, Department of Vascular Surgery
Study officials:
affiliation: Department of Vascular Surgery, CHU de NICE
name: Michel BATT, Professeur
role: PRINCIPAL_INVESTIGATOR
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