Eustachian Tube PatulousNCT04261946
Post Operative Quality of Life After Patulous Eustachian Tube Treatment
An observational study of Eustachian Tube Patulous, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eustachian Tube Patulous
- What is being tested?
- Quality of life survey
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2016to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient consulting in IUFC (NICE) with a unilateral disabling patulous eustachian tube surgically treated
Who may be able to join
- any surgically treateble patient with a unilateral patuluos eustachian tube
Who cannot join
- any patient for whom an other surgical step than the eustachian tube one was needed,
- bilateral desease ,cholesteatoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Eustachian Tube Patulous
- Being tested
- Quality of life survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life surveyOther
Unilateral patulous eustachian tube surgically treated were interviewed about our life's quality by a survey
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: quality of life score in beetwen 2 and 12 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start11 Nov 2016
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eustachian Tube PatulousStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261946
- Sponsor's protocol ID
- 19-PT-01
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Quality of Life Assesment After Patulous Eustachian Tube Surgical Treatment
- ClinicalTrials.gov ID
- NCT04261946
- Acronym / sponsor ID
- 19-PT-01
- Conditions
- Eustachian Tube Patulous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient consulting in IUFC (NICE) with a unilateral disabling patulous eustachian tube surgically treated
Key inclusion criteria (1 listed)
- any surgically treateble patient with a unilateral patuluos eustachian tube
Key exclusion criteria (2 listed)
- any patient for whom an other surgical step than the eustachian tube one was needed,
- bilateral desease ,cholesteatoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life surveyUnilateral patulous eustachian tube surgically treated were interviewed about our life's quality by a survey | Other | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Eustachian Tube Patulous
Recruiting
Nasal Dilator Therapy for Patulous Eustachian Tube Dysfunction
Patulous Eustachian Tube Dysfunction, Eustachian Tube Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eustachian Tube Patulous, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative quality of life (time frame: quality of life score in beetwen 2 and 12 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.