Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation

NCT ID: NCT03950375

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-18

Study Completion Date

2019-04-24

Brief Summary

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The aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.

Detailed Description

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Whereas several surgical techniques exist to perform a cochlear implantation, the most used is the realization of mastoidectomy followed by posterior tympanotomy, in order to expose the round window, which finally permits to access to the cochlea. This procedure might be complicated with facial paresis, loss of residual hearing, because of anatomy relationships in this millimetric area.

CT scan of temporal bone is part of systematic preoperative assessment. Technological advances in radiology during the last decades now provide inframillimetric resolution. Thus, otologic surgeons wish they could anticipate round window exposure from these CT scan. This could decrease the procedure duration, complication occurrence, or improve surgical strategy.

Several studies proposed radiological criteria in this aim, from more or less complex measures in preoperative temporal bone CT scan. However, these diagnostic tests performances have not been assessed for most of them, or compared between them.

Conditions

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Cochlear Implantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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cochlear implantation

"cochlear implantation" group : patients undergoing cochlear implantation between December 2018 and June 2019 in the ENT service of Reims universitary hospital.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients undergoing cochlear implantation in Reims universitary hospital during the inclusion period
* patients who agree to participate in the study
* patients who had preoperative temporal bone CT scan

Exclusion Criteria

* temporal bone malformation on temporal bone CT scan or MRI
* chronic otitis media (except simple middle ear effusion)
* middle ear surgery antecedent
* cochlear implant in the context of a reimplantation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damien JOLLY

Reims, , France

Site Status

Countries

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France

Other Identifiers

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PO18155

Identifier Type: -

Identifier Source: org_study_id

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