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Completed

NCT Number: NCT00559520

The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

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

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Key information

Conditions

Undernutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de NICE, Department of Vascular Surgery

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMPACT

Dietary Supplement

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

Oral IMPACT

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Collaborators

  • Novartis

Registry information

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2007
Registry last updated
Dec 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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