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

NCT03589209 | Unknown

• 1 other identifier: 7052
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tympanostomy Tube Insertion

Keywords

Round window visibility; Cochlear implantation

Outcome Measures

Primary Outcomes (1)

• Measure of the correlation between preoperative CT measurements and the visibility of the round window observed intraoperatively (based on the operative records)

  Analysis of patient records (operative reports and preoperative CT-scan) from patients who underwent cochlear implantation between 01/01/2010 and 01/03/2018.

  1 day after cochlear implantation surgery

Eligibility Criteria

• Age: 9 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Implanted cochlear subject in the ENT department of Strasbourg between 1st January 2010 and 1st March 2018

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service D'Orl Et de Chirurgie Cervico-Faciale

Strasbourg, 67091, France

RECRUITING

Study Officials

• Anne CHARPIOT, MD, PhD

  University Hospital, Strasbourg, France

  STUDY DIRECTOR

Central Study Contacts

Anne CHARPIOT, MD, PhD

CONTACT

33 3 88 12 76 49; anne.charpiot@chru-strasbourg.fr

Carine EYERMANN, MD

CONTACT

33 3 88 12 76 49; Carine.eyermann@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 17, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 19, 2018

Record last verified: 2018-06

Locations

FR (1)