Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation

Round Window Visibility Prediction From Preoperative Scanner in Cochlear Implantation: Literature Review and Radiologic Criteria Evaluation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03950375

Acronym

R-PO18155

Enrollment

Registered

2019-05-15

Start date

2018-12-18

Completion date

2019-04-24

Last updated

2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Implantation

Keywords

Sensorineural Hearing Loss, Round Window, ear surgery, Cochlear implantation

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

: patients who have : * 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

Design outcomes

Primary

Measure	Time frame	Description
peroperative round window exposure	Day 0	peroperative round window exposure evaluated according to St Thomas' Hospital classification: * visible (classes I and II) and not visible (class III) * easily visible (classes I and IIa) and not easily visible (class IIb and III)

Countries

France

Outcome results