Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation (R-PO18155)

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

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

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• France
  • Reims, France
    • Damien JOLLY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with cochlear implantation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2018
• Primary Completion (Actual): April 24, 2019
• Study Completion (Actual): April 24, 2019

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Sensorineural Hearing Loss; Cochlear implantation; Round Window; ear surgery
• Other Study ID Numbers: PO18155

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No