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Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia (SPOC)

R

Rennes University Hospital

Status

Completed

Conditions

Otosclerosis
Otosclerosis Surgery

Treatments

Drug: Local anesthetic
Drug: general anesthetic

Study type

Observational

Funder types

Other

Identifiers

NCT03888079
35RC18_3061_SPOC

Details and patient eligibility

About

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

Full 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 .

Enrollment

103 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

103 participants in 2 patient groups

Local anesthetic
Description:
Patients who chose local anesthesia for their surgery
Treatment:
Drug: Local anesthetic
General anesthetic
Description:
Patients who chose general anesthesia for their surgery
Treatment:
Drug: general anesthetic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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