The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery
Primary Purpose
Undernutrition
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Impact
Oral Impact
Sponsored by
About this trial
This is an interventional screening trial for Undernutrition focused on measuring Patients, Suffering, Undernutrition, Requiring, Vascular, Surgery
Eligibility 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
Sites / Locations
- CHU de NICE, Department of Vascular Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Impact
Oral Impact
Arm Description
patient receiving 3 drinks "Impact" a day during 5 days before surgery
Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery
Outcomes
Primary Outcome Measures
Weight
Arisen of an infectious complication
Arisen of non infectious complication
Secondary Outcome Measures
Primary and secondary permeability
Pain
Healing
Full Information
NCT ID
NCT00559520
First Posted
November 14, 2007
Last Updated
December 8, 2011
Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00559520
Brief Title
The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery
Official Title
The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition
Keywords
Patients, Suffering, Undernutrition, Requiring, Vascular, Surgery
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Impact
Arm Type
Active Comparator
Arm Description
patient receiving 3 drinks "Impact" a day during 5 days before surgery
Arm Title
Oral Impact
Arm Type
Experimental
Arm Description
Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Impact
Intervention Description
Patient receiving 3 drinks "Impact" a day during 5 days before surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Impact
Intervention Description
Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery
Primary Outcome Measure Information:
Title
Weight
Time Frame
before surgery, five days and thirty days after surgery
Title
Arisen of an infectious complication
Time Frame
during the period of 30 days following the surgery
Title
Arisen of non infectious complication
Time Frame
during the period of 30 days following the surgery
Secondary Outcome Measure Information:
Title
Primary and secondary permeability
Time Frame
at 5 and 30 days after surgery
Title
Pain
Time Frame
at 5 and 30 days after surgery
Title
Healing
Time Frame
at 5 and 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel BATT, Professeur
Organizational Affiliation
Department of Vascular Surgery, CHU de NICE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de NICE, Department of Vascular Surgery
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Citations:
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The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery
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