NCT04194788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 29, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2021

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

December 9, 2019

Last Update Submit

May 4, 2023

Conditions

Orthopedic Disorder of SpineSmell Disorder

Outcome Measures

Primary Outcomes (1)

  • Changes in olfaction threshold

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

    Day before surgery and first day after surgery

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing spine surgery.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Location

MeSH Terms

Conditions

Olfaction Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matteo Briguglio

    IRCCS Istituto Ortopedico Galeazzi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 11, 2019

Study Start

April 29, 2021

Primary Completion

July 27, 2021

Study Completion

July 27, 2021

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

IT(1)