Associations of Pre- and Intraoperative Endoscopic Findin... | NCT04672187

Studies
Associations of Pre- and Intraoperative Endoscopic Findings of Middle Ear Status in Cholesteatoma

NCT04672187

Sponsor

Prince of Songkla University

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

41Actual

Phase

Not provided

Conditions

Middle Ear Cholesteatoma

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Nov 1, 2019Actual

Completion Date

Nov 1, 2019Actual

First Submitted Date

Dec 11, 2020

First Submission Date that Met QC Criteria

Dec 11, 2020

First Posted Date

Dec 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to assess the accuracy of preoperative HRCT of the temporal bone combined with the preoperative audiologic assessment compared with the intraoperative endoscopic middle ear finding.

Detailed Description

The information of the preoperative HRCT scanning of the middle ear cavity in cholesteatoma combined with the preoperative audiologic assessment could be informed the intraoperative middle ear finding in the patients who were diagnosed with chronic otitis media with cholesteatoma, which influence the plan of surgical management. Whether these preoperative assessments can predict the intraoperative finding is unclear. The aim of this study is to assess the accuracy of preoperative HRCT of the temporal bone combined with the preoperative audiologic assessment compared with the intraoperative endoscopic middle ear finding.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
predictive factor of intraoperative endoscopic finding from preoperative ct finding and preoperative audiological assessment	the association of preoperative ct finding and preoperative audiological assessment compared with intraoperative endoscopic middle ear finding in middle cholestaetoma	2 years

Secondary Outcomes

Measure	Description	Time Frame
accuracy between preoperative ct finding and intraoperative endoscopic finding	accuracy between preoperative ct finding and intraoperative endoscopic finding of middle ear cholesteatoma	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients included in this study had otorrhea, hearing loss, or aural fullness that last more than 3 months. Otological examination revealed tympanic membrane perforation or retraction, along with cholesteatoma.

Exclusion Criteria:

Patients who had a previous temporal bone fracture, concomitant with congenital craniofacial anomalies, or underwent previous otologic surgery were excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

We prospectively evaluated the preoperative HRCT scanning of the temporal bone and preoperative audiologic assessment compared with an intraoperative endoscopic finding of patients who were diagnosed with chronic otitis media with cholesteatoma and scheduled to a primary surgery at Otolaryngology department, Songklanagarind hospital, Prince of Songkla University between November 2017 to November 2019.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuvatiya Plodpai, MD	Faculty of Medicine, Prince of Songkla University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Prince of Songkla University		Hat Yai	Changwat Songkhla	90110	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D018424	Cholesteatoma, Middle Ear

Ancestor Terms

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D002781	Cholesteatoma
D007642	Keratosis

Browse Leaves

Not provided

Browse Branches

Not provided