Post Operative Quality of Life After Patulous Eustachian Tube Treatment

Completed

• Conditions: Eustachian Tube Patulous

• Registration Number: NCT04261946
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-11-11
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2019-11
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2020-02-06
• Last Update Submitted: 2020-02-06
• Study First Posted: 2020-02-10
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• any surgically treateble patient with a unilateral patuluos eustachian tube

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative quality of life	quality of life score in beetwen 2 and 12 month postoperatively	glasgow 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).

Trial Locations

Locations (1)

Institut Universitaire de la Face et du Cou; 🇫🇷 Nice, France