Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation

Cochlear Implantation Clinical Trial

— R-PO18155  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950375
• Other study ID #: PO18155
• Status: Completed
• Start date: December 18, 2018
• Est. completion date: April 24, 2019

Study information

• Verified date: June 2020
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 24, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implantation

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peroperative round window exposure	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)	Day 0