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Completed

NCT Number: NCT04261946

Post Operative Quality of Life After Patulous Eustachian Tube 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Universitaire de la Face et du Cou

Nice, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life survey

Other

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

Primary outcomes

  1. Postoperative quality of life

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 10, 2020
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.