Post Operative Quality of Life After Patulous Eustachian Tube Treatment

Eustachian Tube Patulous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261946
• Other study ID #: 19-PT-01
• Status: Completed
• Start date: November 11, 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: November 2019
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Eustachian Tube Patulous

Intervention

Other:
• Quality of life survey
Unilateral patulous eustachian tube surgically treated were interviewed about our life's quality by a survey

Locations

Country	Name	City	State
France	Institut Universitaire de la Face et du Cou	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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