Olfaction Changes in Patients Undergoing Spine Surgery | NCT04194788

Studies
Olfaction Changes in Patients Undergoing Spine Surgery

NCT04194788

Sponsor

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

Status

Completed

Last Update Posted

May 6, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Orthopedic Disorder of Spine
Smell Disorder

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
L4133	Other Grant/Funding Number	Italian Ministry of Health

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 29, 2021Actual

Primary Completion Date

Jul 27, 2021Actual

Completion Date

Jul 27, 2021Actual

First Submitted Date

Dec 9, 2019

First Submission Date that Met QC Criteria

Dec 10, 2019

First Posted Date

Dec 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2023

Last Update Posted Date

May 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing spine surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matteo Briguglio	IRCCS Istituto Ortopedico Galeazzi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Istituto Ortopedico Galeazzi		Milan			Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000857	Olfaction Disorders

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided