Post Operative Quality of Life After Patulous Eustachian Tube Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Eustachian Tube Patulous
• Intervention / Treatment: Other: Quality of life survey

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• France
  • Nice, France
    • Institut Universitaire de la Face et du Cou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2016
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 19-PT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No