Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

Otosclerosis Clinical Trial

— SPOC  

Official title:

Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03888079
• Other study ID #: 35RC18_3061_SPOC
• Status: Completed
• Start date: January 11, 2019
• Est. completion date: June 21, 2021

Study information

• Verified date: March 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 21, 2021
• Est. primary completion date: March 3, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Otosclerosis
• Otosclerosis Surgery

Intervention

Drug:
• Local anesthetic
1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia
• general anesthetic
Endotracheal intubation, intravenous narcotic agents, and inhaled agents

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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