Preoperative Immunonutrition in Patients Undergoing Spine Surgery
Key facts
- Who runs it
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 10 people enrolled
- Started
- 16 Mar 2022
- Ended
- 5 Nov 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Immuno-nutrition
- Record updated
- 13 November 2026
- Why it stopped
- Poor accrual
Who can take part
- Age
- 60 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Therapy with other supplements at the time of the first visit 0
- Diagnosis of neurological or psychiatric disorders
- 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
- American Society of Anesthesiology (ASA) risk: 4
- No cervical arthrodesis
- Revisions
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 Orthopedics and infection rates are potentially life-threatening complications, with the highest morbidity, mortality, and healthcare costs. Most patients undergoing orthopedic surgery are elderly, malnourished, osteosarcopenic, sedentary, anemic, and suffer from low levels of vitamin D. A mono-nutrient supplement may be not sufficient for supporting the arthrodesis techniques, which are invasive open surgeries procedures with significant blood losses and the need of transfusions. In this therapeutic area, immuno-nutrition has been used in spine surgery, with the reduction of complications, revisions, and readmissions. In addition, prosthetic surgery outcomes have been observed to ameliorate by using this nutritional support. Therefore, preoperative oral immuno-nutrition therapy may be applied in older adults undergoing spine surgery to improve patients' outcomes and reduce complications.
Read full original descriptionShow less
This is a randomized, controlled, open-label, 2-arm non-parallel-group, single-center interventional study to assess the efficacy of an immuno-nutrition therapy vs. hospital standard of care in spine surgery to improve patients' outcomes. This is a single primary endpoint study. A total of 136 patients from IRCCS Orthopedic Institute Galeazzi in Italy will be recruited and assigned in a 1:1 ratio to the treatment arm.
The 2 groups in the trial
- Supplemented patientsTreatment being tested
Treatment: Immuno-nutrition
- Standard of careNo study treatment, for comparison
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Immunonnutrition in Spine Surgery to Improve Patient's Outcome: a Randomized Controlled Trial
- Record updated
- 13 November 2026