Post Operative Quality of Life After Patulous Eustachian Tube Treatment

NCT04261946 | Completed

• 1 other identifier: 19-PT-01
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Eustachian Tube Patulous

Outcome Measures

Primary Outcomes (1)

• Postoperative quality of life

  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).

  quality of life score in beetwen 2 and 12 month postoperatively

Interventions

Quality of life survey OTHER

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

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

Any patient consulting in IUFC (NICE) with a unilateral disabling patulous eustachian tube surgically treated

You may qualify if:

• any surgically treateble patient with a unilateral patuluos eustachian tube

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Institut Universitaire de la Face et du Cou

Nice, France

Location

Study Design

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

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: February 10, 2020
• Study Start: November 11, 2016
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: February 10, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)