| Registry | NCT03888079, acronym SPOC |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 103 (Actual) |
| Sponsor | Rennes University Hospital (Other) |
| Conditions | Otosclerosis, Otosclerosis Surgery |
| Interventions | Local anesthetic, general anesthetic (Drug) |
| Dates | start 2019-01-11, primary completion 2021-03-03, completion 2021-06-21, first posted 2019-03-25, last updated 2022-04-05 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Otosclerosis All trials for Otosclerosis Surgery All trials of Local anesthetic All trials of general anesthetic
Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.
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 .
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Local anesthetic | Drug: Local anesthetic | Patients who chose local anesthesia for their surgery | |
| General anesthetic | Drug: general anesthetic | Patients who chose general anesthesia for their surgery |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Rennes | Rennes | France |