Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 11, 2021

Detailed Description

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 .

Interventions

  • Drug: Local anesthetic
    • 1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia
  • Drug: general anesthetic
    • Endotracheal intubation, intravenous narcotic agents, and inhaled agents

Arms, Groups and Cohorts

  • Local anesthetic
    • Patients who chose local anesthesia for their surgery
  • General anesthetic
    • Patients who chose general anesthesia for their surgery

Clinical Trial Outcome Measures

Primary Measures

  • Visual comfort scale (EVA type ruler)
    • Time Frame: 10 days after surgery
    • 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

Secondary Measures

  • Glasgow Benefit Inventory questionnaire GBI
    • Time Frame: 3 months after surgery
    • 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.

Participating in This Clinical Trial

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. – PrĂ© 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Rennes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Benoit Godey, PH-PD, Principal Investigator, Rennes University Hospital
  • Overall Contact(s)
    • kristell COAT, 2 99 28 25 55, kristell.coal@chu-rennes.fr

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