Status:
UNKNOWN
Preoperative Immunonutrition in Patients Undergoing Spine Surgery
Lead Sponsor:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Conditions:
Arthrosis; Spine
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
A malnutritional status is known to be associated with altered immune function, reduced function, and worsen outcomes after orthopedic surgery. Medical and surgical complications are not uncommon in O...
Eligibility Criteria
Inclusion
- male and female sex, of all ethnicities, aged over 60
- arthrodesis involving ≥ 6 vertebrae
- American Society of Anesthesiology (ASA) risk: 1, 2, or 3
- Absence of neurological or psychiatric disorders
- Signing of informed consent and consent to collaborate in all study procedures
- Patients who meet the clinical requirements to undergo their first spinal surgery
Exclusion
- American Society of Anesthesiology (ASA) risk: 4
- No cervical arthrodesis
- Diagnosis of neurological or psychiatric disorders
- Revisions
- Therapy with other supplements at the time of the first visit 0
- Known allergy or adverse food reactions
- Chronic inflammatory or autoimmune diseases (e.g. rheumatoid arthritis)
- Gastrointestinal disorders
- Conditions that do not allow to undergo surgery
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT05372289
Start Date
March 16 2022
End Date
February 1 2024
Last Update
May 6 2023
Active Locations (1)
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1
IRCCS Istituto Ortopedico Galeazzi
Milan, Italy