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

NCT04899011 | Completed

• 1 other identifier: 21IUFC01
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Ear Middle Problems

Outcome Measures

Primary Outcomes (1)

• Frequency, duration and characteristics of taste and salivary disturbance after middle ear surgery and impact on quality of life.

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

  1 year

Secondary Outcomes (2)

• Influence of CTN injury type: stretch versus sectionned, influence of otologic desease

  1 day

• Influence of use between endoscope or microscope surgery

  1 day

Study Arms (1)

Middle ear surgery

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Middle ear surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with middle ear surgery

You may qualify if:

• Patient undergoing middle ear surgery
• Acceptation to participate
• under 18 years old, parental authorization.

You may not qualify if:

• Taste disturbance before surgery
• Patients with guardianship or tutelage measure

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nicolas GUEVARA, Dr

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: May 30, 2021
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)