Post Operative Quality of Life After Patulous Eustachian Tube Treatment

NCT ID: NCT04261946

Last Updated: 2020-02-10

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

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-11

Study Completion Date

2019-08-31

Brief Summary

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Patulous eustachian tube (ET) is a usually asymptomatic poorly known ET pathology. When it becomes so and thus impairs the eardrum (retraction pockets, cholesteatoma) or patients' quality of life (QoL), therapeutic management is proposed. The surgical treatment has diversified in recent years but remains dominated by filling spaces around the ET (autologous fat and/or septal cartilage grafting). Efficiency is traditionally objectivized by dynamic otoscopy, tubomanometry and audiometry, but QoL must also be taken into account and its postoperative assesment was the objective of this work.

Materials and Methods This is a unicentric retrospective study conducted from November 2016 to March 2019 on all patients with a disabling patulous ET, single or bilateral, managed surgically by autologous fat and/or septal cartilage grafting in investigators ENT department. Patients for whom a concomitant procedure was performed were excluded from the study.

The post-operative QoL assessment was performed using the Glasgow Benefit Inventory (GBI), postoperative self-administered questionnaire validated in ENT, including a general, physical and social evaluation. Predictive factors for QoL improvement were investigated among pre-, per- and post-operative clinical data.

Detailed Description

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Conditions

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Eustachian Tube Patulous

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Quality of life survey

Unilateral patulous eustachian tube surgically treated were interviewed about our life's quality by a survey

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* any surgically treateble patient with a unilateral patuluos eustachian tube

Exclusion Criteria

* any patient for whom an other surgical step than the eustachian tube one was needed,
* bilateral desease ,cholesteatoma
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Universitaire de la Face et du Cou

Nice, , France

Site Status

Countries

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France

Other Identifiers

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19-PT-01

Identifier Type: -

Identifier Source: org_study_id

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