Prediciton of the Round Window Visibility Through Posterior Tympanotomy by CT Scan Analysis

Preoperative CT Scan Analysis to Predict Perioperative Round Window Visibility Through the Posterior Tympanotoy in Cochlear Implant Surgery

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03589209

Enrollment

100

Registered

2018-07-17

Start date

2018-06-01

Completion date

2019-06-30

Last updated

2018-07-19

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

Conditions

Tympanostomy Tube Insertion

Keywords

Round window visibility, Cochlear implantation

Brief summary

It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery. The primary purpose of the study is to define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window. Define relevant CT measurements on the preoperative scanner to predict the perioperative visibility of the round window. The secondary purpose is to validate the investigator's scanner reading protocol for a prospective study.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Months to No maximum

Healthy volunteers

Inclusion criteria

* Aged subject from 9 months and over * Implanted cochlear subject in the ENT department of Strasbourg between 1st January 2010 and 1st March 2018 * Subject (or the holders of parental authority in the case of minors) having agreed to the use of medical data for the purpose of this research.

Exclusion criteria

* Refusal of the patient to participate in the study * CROP does not make it possible to evaluate the visibility of the FR * Preoperative or uninterpretable scanner * Major anatomical malformation * Subject under the protection of justice * Subject under guardianship or curatorship

Design outcomes

Primary

Measure	Time frame	Description
Measure of the correlation between preoperative CT measurements and the visibility of the round window observed intraoperatively (based on the operative records)	1 day after cochlear implantation surgery	Analysis of patient records (operative reports and preoperative CT-scan) from patients who underwent cochlear implantation between 01/01/2010 and 01/03/2018.

Countries

France

Contacts

Primary ContactAnne CHARPIOT, MD, PhD

anne.charpiot@chru-strasbourg.fr33 3 88 12 76 49

Backup ContactCarine EYERMANN, MD

Carine.eyermann@chru-strasbourg.fr33 3 88 12 76 49

Outcome results