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The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00559520
Enrollment
250
Registered
2007-11-16
Start date
2002-02-28
Completion date
2011-12-31
Last updated
2011-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Undernutrition

Keywords

Patients, Suffering, Undernutrition, Requiring, Vascular, Surgery

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

Interventions

DIETARY_SUPPLEMENTImpact

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

DIETARY_SUPPLEMENTOral Impact

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

Sponsors

Novartis
CollaboratorINDUSTRY
Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Weightbefore surgery, five days and thirty days after surgery
Arisen of an infectious complicationduring the period of 30 days following the surgery
Arisen of non infectious complicationduring the period of 30 days following the surgery

Secondary

MeasureTime frame
Primary and secondary permeabilityat 5 and 30 days after surgery
Painat 5 and 30 days after surgery
Healingat 5 and 30 days after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026