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

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

Study Overview

• Status: Completed
• Conditions: Otosclerosis; Otosclerosis Surgery
• Intervention / Treatment: Drug: Local anesthetic; Drug: general anesthetic

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 .

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Centre Hospitalier Universitaire de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients suffering from otosclerosis who have surgical indication

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Local anesthetic; Patients who chose local anesthesia for their surgery	Drug: Local anesthetic; 1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia
General anesthetic; Patients who chose general anesthesia for their surgery	Drug: general anesthetic; Endotracheal intubation, intravenous narcotic agents, and inhaled agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual comfort scale (EVA type ruler)	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	10 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Benefit Inventory questionnaire GBI	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.	3 months after surgery

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Benoit Godey, PH-PD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2019
• Primary Completion (Actual): March 3, 2021
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: general anesthesia; Otosclerosis; otosclerosis surgery; local anesthesia; comfort assessment; Glasgow Benefit Inventory questionnaire; hearing results
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otosclerosis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Anesthetics, General
• Other Study ID Numbers: 35RC18_3061_SPOC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No