The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

Phase 4

Completed

• Conditions: Undernutrition
• Interventions: Dietary Supplement: Impact; Dietary Supplement: Oral Impact

• Registration Number: NCT00559520
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Primary Completion: 2011-11
• Status Verified: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-08
• Last Update Posted: 2011-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Impact	Impact	patient receiving 3 drinks "Impact" a day during 5 days before surgery
Oral Impact	Oral Impact	Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery

Primary Outcome Measures

Name	Time	Method
Weight	before surgery, five days and thirty days after surgery
Arisen of an infectious complication	during the period of 30 days following the surgery
Arisen of non infectious complication	during the period of 30 days following the surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de NICE, Department of Vascular Surgery; 🇫🇷 Nice, France