The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

December 8, 2011 updated by: Centre Hospitalier Universitaire de Nice

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • CHU de NICE, Department of Vascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Impact
patient receiving 3 drinks "Impact" a day during 5 days before surgery
Dietary supplement: Impact
Patient receiving 3 drinks "Impact" a day during 5 days before surgery
Experimental: Oral Impact
Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery
Dietary supplement: Oral Impact
Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: before surgery, five days and thirty days after surgery
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
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
during the period of 30 days following the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Primary and secondary permeability
Time Frame: at 5 and 30 days after surgery
at 5 and 30 days after surgery
Pain
Time Frame: at 5 and 30 days after surgery
at 5 and 30 days after surgery
Healing
Time Frame: at 5 and 30 days after surgery
at 5 and 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Collaborators

Novartis

Investigators

  • Principal Investigator: Michel BATT, Professeur, Department of Vascular Surgery, CHU de NICE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 14, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

December 9, 2011

Last Update Submitted That Met QC Criteria

December 8, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC 2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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