Sponsor study identifier
observational
18
1 country
1
Study Start
November 11, 2016
Actual (reported)Primary Completion
August 31, 2019
Actual (reported)Study Completion
August 31, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 11, 2016
Actual (reported)August 31, 2019
Actual (reported)August 31, 2019
Actual (reported)November 20, 2019
Actual (reported)February 10, 2020
Actual (reported)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
Unilateral patulous eustachian tube surgically treated were interviewed about our life's quality by a survey
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Any patient consulting in IUFC (NICE) with a unilateral disabling patulous eustachian tube surgically treated
Institut Universitaire de la Face et du Cou
Nice, France
18 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2019
First Posted
February 10, 2020
Study Start
November 11, 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
August 31, 2019
Actual (reported)Study Completion
August 31, 2019
Actual (reported)Last Updated
February 10, 2020
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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