Orthopedic Disorder of SpineNCT04194788
Olfaction Changes in Patients Undergoing Spine Surgery
An observational study of Orthopedic Disorder of Spine and Smell Disorder, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
This observational prospective study evaluates perioperative olfaction alterations, comprising changes in threshold value, discrimination and identification, which occur in spine patients. The single group is subjected to a preoperative and a postoperative assessment. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder of Spine, Smell Disorder
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 29 Apr 2021to 27 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing spine surgery.
Who may be able to join
- Males or females
- Caucasian race
- Between 50 and 85 years of age
- Candidates to spine surgery
- Acceptance and signing of informed consent
Who cannot join
- Past or present cancer
- Heart failure
- Kidney failure (III-IV)
- Past or present neuropsychiatric disorders
- Heavy smokers (over/equal 3 cigarettes per day)
- Smell disorders
- Rhinitis
- Allergies to the respiratory system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Pilot Study on Olfaction Alterations That Occur in Spine Patients After Surgery
This observational prospective study evaluates perioperative olfaction alterations, comprising changes in threshold value, discrimination and identification, which occur in spine patients. The single group is subjected to a preoperative and a postoperative assessment.
- Conditions
- Orthopedic Disorder of Spine, Smell Disorder
- Medical subject headings
- Olfaction Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in olfaction threshold
Changes in the olfaction threshold evaluated with a series of solutions having different concentrations of aromas
Measured: Day before surgery and first day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start29 Apr 2021
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic Disorder of SpineStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Briguglio, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194788
- Sponsor's protocol ID
- TASTEODOR (PI: M Briguglio)
- Other IDs
- L4133
- Status last verified
- May 2023
- First submitted
- 9 Dec 2019
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Pilot Study on Olfaction Alterations That Occur in Spine Patients After Surgery
- ClinicalTrials.gov ID
- NCT04194788
- Acronym / sponsor ID
- TASTEODOR (PI: M Briguglio)
- Conditions
- Orthopedic Disorder of Spine, Smell Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational prospective study evaluates perioperative olfaction alterations, comprising changes in threshold value, discrimination and identification, which occur in spine patients. The single group is subjected to a preoperative and a postoperative assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing spine surgery.
Key inclusion criteria (5 listed)
- Males or females
- Caucasian race
- Between 50 and 85 years of age
- Candidates to spine surgery
- Acceptance and signing of informed consent
Key exclusion criteria (8 listed)
- Past or present cancer
- Heart failure
- Kidney failure (III-IV)
- Past or present neuropsychiatric disorders
- Heavy smokers (over/equal 3 cigarettes per day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in olfaction threshold
Time frame: Day before surgery and first day after surgery
Changes in the olfaction threshold evaluated with a series of solutions having different concentrations of aromas
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Briguglio principal investigator
IRCCS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder of Spine and Smell Disorder, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in olfaction threshold (time frame: Day before surgery and first day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.