The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 4

Conditions: Undernutrition

Treatments: Dietary Supplement: Oral Impact; Dietary Supplement: Impact

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00559520

PHRC 2004

Details and patient eligibility

About

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

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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250 participants in 2 patient groups

Impact

Active Comparator group

Description:

patient receiving 3 drinks "Impact" a day during 5 days before surgery

Treatment:

Dietary Supplement: Impact

Oral Impact

Experimental group

Description:

Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery

Treatment:

Dietary Supplement: Oral Impact