The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00559520
First received: November 14, 2007
Last updated: December 8, 2011
Last verified: December 2011

November 14, 2007
December 8, 2011
February 2002
November 2011   (final data collection date for primary outcome measure)
  • Weight [ Time Frame: before surgery, five days and thirty days after surgery ] [ Designated as safety issue: No ]
  • Arisen of an infectious complication [ Time Frame: during the period of 30 days following the surgery ] [ Designated as safety issue: No ]
  • Arisen of non infectious complication [ Time Frame: during the period of 30 days following the surgery ] [ Designated as safety issue: No ]
  • -Weight [ Time Frame: 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 ]
  • Arisen of non infectious complication [ Time Frame: during the period of 30 days following the surgery ]
Complete list of historical versions of study NCT00559520 on ClinicalTrials.gov Archive Site
  • Primary and secondary permeability [ Time Frame: at 5 and 30 days after surgery ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: at 5 and 30 days after surgery ] [ Designated as safety issue: No ]
  • Healing [ Time Frame: at 5 and 30 days after surgery ] [ Designated as safety issue: No ]
  • primary and secondary permeability [ Time Frame: at 5 and 30 days after surgery ]
  • pain [ Time Frame: at 5 and 30 days after surgery ]
  • healing [ Time Frame: at 5 and 30 days after surgery ]
Not Provided
Not Provided
 
The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery
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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
Undernutrition
  • Dietary Supplement: Impact
    Patient receiving 3 drinks "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
  • Active Comparator: Impact
    patient receiving 3 drinks "Impact" a day during 5 days before surgery
    Intervention: Dietary Supplement: Impact
  • Experimental: Oral Impact
    Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery
    Intervention: Dietary Supplement: Oral Impact

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
December 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00559520
PHRC 2004
No
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Novartis
Principal Investigator: Michel BATT, Professeur Department of Vascular Surgery, CHU de NICE
Centre Hospitalier Universitaire de Nice
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP