CompletedNot Applicable

Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

France103 participantsStarted 2019-01-11

Plain-language summary

Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Patients older than 18 years suffering from otosclerosis who have surgical indication. * Patients who want surgical treatment for their otosclerosis * Clinic : Deafness with social prejudice and normal otoscopic exam * Audiometric : conductive or mixed hearing loss with abolition of the aural reflex. Audiometric threshold more than 30decibel (dB) and air bone gap more important than 20dB. * Pré operative scan in favor of otosclerosis * Diagnosis confirmation during the surgery with stapes sclerotic's attachments to the oval window Exclusion criteria: * History of ear surgery * No medical objection to local anesthesia * No medical objection to general anesthesia * No medical objection to ear surgery * No legal protection for adults * No participation refusal

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual comfort scale (EVA type ruler)

Timeframe: 10 days after surgery

Trial details

NCT IDNCT03888079

SponsorRennes University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-03-03

View on ClinicalTrials.gov More Otosclerosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.