Clinical Trials Directory

Trials / Completed

CompletedNCT04261946

Post Operative Quality of Life After Patulous Eustachian Tube Treatment

Post Operative Quality of Life Assesment After Patulous Eustachian Tube Surgical Treatment

Status
Completed
Phase
Study type
Observational
Enrollment
18 (actual)
Sponsor
Centre Hospitalier Universitaire de Nice · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERQuality of life surveyUnilateral patulous eustachian tube surgically treated were interviewed about our life's quality by a survey

Timeline

Start date
2016-11-11
Primary completion
2019-08-31
Completion
2019-08-31
First posted
2020-02-10
Last updated
2020-02-10

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04261946. Inclusion in this directory is not an endorsement.