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The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

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ClinicalTrials.gov Identifier: NCT00559520
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : December 9, 2011
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Undernutrition Dietary Supplement: Impact Dietary Supplement: Oral Impact Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery
Study Start Date : February 2002
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

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



Primary Outcome Measures :
  1. Weight [ Time Frame: before surgery, five days and thirty days after surgery ]
  2. Arisen of an infectious complication [ Time Frame: during the period of 30 days following the surgery ]
  3. Arisen of non infectious complication [ Time Frame: during the period of 30 days following the surgery ]

Secondary Outcome Measures :
  1. Primary and secondary permeability [ Time Frame: at 5 and 30 days after surgery ]
  2. Pain [ Time Frame: at 5 and 30 days after surgery ]
  3. Healing [ Time Frame: at 5 and 30 days after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559520


Locations
France
CHU de NICE, Department of Vascular Surgery
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Novartis
Investigators
Principal Investigator: Michel BATT, Professeur Department of Vascular Surgery, CHU de NICE

Publications:

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00559520     History of Changes
Other Study ID Numbers: PHRC 2004
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: December 9, 2011
Last Verified: December 2011

Keywords provided by Centre Hospitalier Universitaire de Nice:
Patients
Suffering
Undernutrition
Requiring
Vascular
Surgery

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders