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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
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Undernutrition focused on measuring Patients, Suffering, Undernutrition, Requiring, Vascular, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 14, 2007
Last Updated
December 8, 2011
Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
Novartis
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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

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The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

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