Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

Completed

• Conditions: Otosclerosis; Otosclerosis Surgery
• Interventions: Drug: general anesthetic; Drug: Local anesthetic

• Registration Number: NCT03888079
• Lead Sponsor: Rennes University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2019-01-11
• Study First Submitted: 2019-02-04
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-25
• Primary Completion: 2021-03-03
• Study Completion: 2021-06-21
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General anesthetic	general anesthetic	Patients who chose general anesthesia for their surgery
Local anesthetic	Local anesthetic	Patients who chose local anesthesia for their surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Rennes; 🇫🇷 Rennes, France