Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

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

Detailed Description
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The care system will not differ from the usually treatment of patients. Patients will decided about the type of anesthesia (local or general) after detailed description of both procedures. All operations will be performed by the same surgeon and the same basic surgical technique. The only difference is that patients included in thi study will have to complete a satisfactory survey 10 days after surgery and a GBI questionnaire 3 months after surgery, during the post operative consultations .

Official Title
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Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

Conditions
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Otosclerosis, Otosclerosis Surgery

Intervention / Treatment
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* Drug: Local anesthetic
* Drug: general anesthetic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Local anesthetic<br>Patients who chose local anesthesia for their surgery | Drug: Local anesthetic<br>* 1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia<br>|
| General anesthetic<br>Patients who chose general anesthesia for their surgery | Drug: general anesthetic<br>* Endotracheal intubation, intravenous narcotic agents, and inhaled agents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual comfort scale (EVA type ruler) | respondents specify their level of comfort during the surgery by indicating a position along a continuous line between two end-points : Minimum score is 0 (no comfort) and maximum is 10 (very comfortable) during surgery | 10 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Benefit Inventory questionnaire GBI | Glasgow Benefit Inventory questionnaire GBI (GBI, Robinson et al. 1996). The Glasgow Benefit Inventory (GBI) is a measure of patient benefit developed especially for otorhinolaryngological (ORL) interventions. 18 items in 3 categories defined by social, psychological, and physical perceptions of well-being Responses are based on a 5-point Likert scale, ranging from a large deterioration in health status (1) to a large improvement (5). The total GBI score is then calculated from an average of the Likert scores to give equal weight to each question. The average (1 5) is subtracted by 3 (no change), and the result is multiplied by 50 to produce a GBI score that ranges from 100 (maximum detriment after surgery) to 100 (maximum improvement after the intervention). A GBI score of zero is neutral and indicates no improvement or detriment from the intervention. | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Otosclerosis, otosclerosis surgery, local anesthesia, general anesthesia, comfort assessment, Glasgow Benefit Inventory questionnaire, hearing results