Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

NCT03888079 — Completed, 103 participants, Rennes University Hospital

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RegistryNCT03888079, acronym SPOC
StatusCompleted
Study typeObservational
Enrollment103 (Actual)
SponsorRennes University Hospital (Other)
ConditionsOtosclerosis, Otosclerosis Surgery
InterventionsLocal anesthetic, general anesthetic (Drug)
Datesstart 2019-01-11, primary completion 2021-03-03, completion 2021-06-21, first posted 2019-03-25, last updated 2022-04-05
Locations1 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

-Summary

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

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+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 .

+Arms and interventions

ArmTypeInterventionsDescription
Local anestheticDrug: Local anestheticPatients who chose local anesthesia for their surgery
General anestheticDrug: general anestheticPatients who chose general anesthesia for their surgery
  • 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

+Outcome measures

Primary outcomes

  • Visual comfort scale (EVA type ruler) [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

  • Glasgow Benefit Inventory questionnaire GBI [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.

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Centre Hospitalier Universitaire de RennesRennesFrance

+Investigators