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Post Operative Quality of Life After Patulous Eustachian Tube Treatment

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04261946
Enrollment
18
Registered
2020-02-10
Start date
2016-11-11
Completion date
2019-08-31
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eustachian Tube Patulous

Brief 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.

Interventions

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative quality of lifequality of life score in beetwen 2 and 12 month postoperativelyglasgow benefit inventory : Post-operative quality of life score concerning general, social, and physical aspects studied in 18 questions. A likert scale ranging from -2 to +2 (5 points) evaluate each of 18 points. Positive and higher score mean a better outcome (maximum = 36). Negative and lower score mean a wors outcome (minimum = -36).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026