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Clinical Trials/NCT03888079
NCT03888079
Completed
Not Applicable

Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

Rennes University Hospital1 site in 1 country103 target enrollmentJanuary 11, 2019

Overview

Phase
Not Applicable
Intervention
Local anesthetic
Conditions
Otosclerosis
Sponsor
Rennes University Hospital
Enrollment
103
Locations
1
Primary Endpoint
Visual comfort scale (EVA type ruler)
Status
Completed
Last Updated
4 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
January 11, 2019
End Date
June 21, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Local anesthetic

Patients who chose local anesthesia for their surgery

Intervention: Local anesthetic

General anesthetic

Patients who chose general anesthesia for their surgery

Intervention: general anesthetic

Outcomes

Primary Outcomes

Visual comfort scale (EVA type ruler)

Time Frame: 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)

Study Sites (1)

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