Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study

NCT ID: NCT05182268

Last Updated: 2022-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-01

Study Completion Date

2021-03-30

Brief Summary

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Background: Cholesteatoma is a potentially life-threatening inflammatory lesion that causes hearing loss, ear discharge, and ear pain, and serious complications. For the past several decades, most studies of cholesteatoma have been restricted to microscopic ear surgery. However, a growing body of evidence suggests endoscopic ear surgery is a safe, minimally invasive approach for cholesteatoma management. This thesis aim to investigate and compare the clinical effect between endoscopic and microscopic ear surgery of cholesteatoma.

Materials and methods: The retrospective study included 186 patients with cholesteatoma who received endoscopic or microscopic ear surgery from 11 otorhinolaryngology centers between November 2016 and March 2021. Patients were followed-up for at least 1 year. Audiometry improvement, treatment cost, time, graft success rate and recurrence rate were assessed after surgery.

Detailed Description

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Conditions

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Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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endoscopic ear surgery group(EES)

endoscopic ear surgery

Intervention Type PROCEDURE

a ear surgery via endoscopic

microscopic ear surgery group(MES)

microscopic ear surgery

Intervention Type PROCEDURE

a ear surgery via microscopic

Interventions

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endoscopic ear surgery

a ear surgery via endoscopic

Intervention Type PROCEDURE

microscopic ear surgery

a ear surgery via microscopic

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement
* the extent of disease was confirmed by preoperative HRCT temporal bone
* undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery

Exclusion Criteria

* were lacking in clinical characteristics
* had not preoperative audiometric data
* missed the follow-up data
* were lacking in surgical times
* were microscopic combined endoscopic ear surgery
Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SunYatsenU2H_YangH01

Identifier Type: -

Identifier Source: org_study_id

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