Olfaction Changes in Patients Undergoing Spine Surgery

NCT ID: NCT04194788

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-29

Study Completion Date

2021-07-27

Brief Summary

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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.

Detailed Description

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Conditions

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Orthopedic Disorder of Spine Smell Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matteo Briguglio

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Galeazzi

Locations

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IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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L4133

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TASTEODOR (PI: M Briguglio)

Identifier Type: -

Identifier Source: org_study_id

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