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Olfaction Changes in Patients Undergoing Spine Surgery

Sponsor
Istituto Ortopedico Galeazzi (Other)
Overall Status
Completed
CT.gov ID
NCT04194788
Collaborator
(none)
50
Enrollment
1
Location
2.9
Actual Duration (Months)
17.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Observational Pilot Study on Olfaction Alterations That Occur in Spine Patients After Surgery
    Actual Study Start Date :
    Apr 29, 2021
    Actual Primary Completion Date :
    Jul 27, 2021
    Actual Study Completion Date :
    Jul 27, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Changes in olfaction threshold [Day before surgery and first day after surgery]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Males or females

    • Caucasian race

    • Between 50 and 85 years of age

    • Candidates to spine surgery

    • Acceptance and signing of informed consent

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Istituto Ortopedico Galeazzi Milan Italy 20141

    Sponsors and Collaborators

    • Istituto Ortopedico Galeazzi

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Ortopedico Galeazzi
    ClinicalTrials.gov Identifier:
    NCT04194788
    Other Study ID Numbers:
    • TASTEODOR
    First Posted:
    Dec 11, 2019
    Last Update Posted:
    Sep 2, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Musculoskeletal Diseases
    Spinal Diseases
    Olfaction Disorders
    Disease

    Study Results

    No Results Posted as of Sep 2, 2021