Taste Disturbance After Middle Ear Surgery: Frequency, Duration, Influence of Chorda Tympani Injury and Quality of Life

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04899011
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 31
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief Summary

Chorda tympani nerve (CTN), is a branch of nerve VII, and has two componants: taste sensation from the anterior two thirds of the tongue and salivary secretion from submandibular and sublingual salivary glands.

CTN go throw middle ear between malleus and incus. Due to it anatomic localization, CTN is frequently damage during otologic surgery.

Taste disturbance after middle ear surgery has been describe in literature but results of the various studies are very heterogenous. Moreover, there is no consensus to preserved or sacrificed a traumatize CTN.

We will use questionnaire to evaluate frequency, duration and characteristics of taste disturbance after ear surgery and the impact on the quality of life for those with symptoms.

We will evaluate the Influence of type of CTN injury on taste disturbance.

Condition or Disease	Intervention/Treatment	Phase
Ear Middle Problems	Other: Questionnaire

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Taste Disturbance After Middle Ear Surgery: Frequency, Duration, Influence of Chorda Tympani Injury and Quality of Life
• Anticipated Study Start Date: May 30, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Middle ear surgery	Other: Questionnaire; Questionnaire about taste and salivary disturbance before surgery, 10 days, 4 months and 1 year after surgery. Questionnaires include characteristics of taste disturbance, and specific impact on quality of life.

Outcome Measures

Primary Outcome Measures

1. Frequency, duration and characteristics of taste and salivary disturbance after middle ear surgery and impact on quality of life. [1 year]

   Taste and salivary disturbance will be measure with questionnaire before and during 1 year after middle ear surgery

Secondary Outcome Measures

1. Influence of CTN injury type: stretch versus sectionned, influence of otologic desease [1 day]

   Measure with surgeon questionnaire

2. Influence of use between endoscope or microscope surgery [1 day]

   Measure with surgeon questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient undergoing middle ear surgery

• Acceptation to participate

• under 18 years old, parental authorization.

Exclusion Criteria:

• Taste disturbance before surgery

• Patients with guardianship or tutelage measure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nice	Nice		France	06003

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice

Investigators

• Principal Investigator: Nicolas GUEVARA, Dr, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT04899011
• Other Study ID Numbers: 21IUFC01
• First Posted: May 24, 2021
• Last Update Posted: May 24, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dysgeusia

Study Results

No Results Posted as of May 24, 2021