ClinicalTrials.gg
CompletedNCT04194788Updated May 6, 2023

Olfaction Changes in Patients Undergoing Spine Surgery

An observational study in Orthopedic Disorder of Spine and Smell Disorder, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Completed at 1 site in Italy. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Orthopedic Disorder of Spine
  • Smell Disorder

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03

In context

Olfaction Disorders

70 studies on the registry are indexed under Olfaction Disorders; 18 are open to participants now.

This study's enrollment of 50 is below the median of 81 across 16 observational studies indexed under Olfaction Disorders.

Browse Olfaction Disorders studies →

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients undergoing spine surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Males or females
  • Caucasian race
  • Between 50 and 85 years of age
  • Candidates to spine surgery
  • Acceptance and signing of

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Changes in olfaction threshold

    Changes in the olfaction threshold evaluated with a series of solutions having different concentrations of aromas

    Time frame: Day before surgery and first day after surgery

07

Study locations

1 site
  • IRCCS Istituto Ortopedico Galeazzi
    Milan, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04194788
Responsible party
Sponsor
First posted
Dec 11, 2019
Start date
Apr 29, 2021
Primary completion
Jul 27, 2021
Completion
Jul 27, 2021
Last update
May 6, 2023

Study contacts

Matteo Briguglio
principal investigator · IRCCS Istituto Ortopedico Galeazzi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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