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Completed

NCT Number: NCT03888079

Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

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

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Key information

Conditions

Otosclerosis Ear Diseases Otorhinolaryngologic Diseases Otosclerosis Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

About this study

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 .

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local anesthetic

Drug

1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia

General anesthetic

Drug

Endotracheal intubation, intravenous narcotic agents, and inhaled agents

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: SPOC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2019
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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