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

Completed

• Conditions: Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect
• Interventions: Procedure: microscopic ear surgery; Procedure: endoscopic ear surgery

• Registration Number: NCT05182268
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2021-12
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2022-01-05
• Last Update Submitted: 2022-01-05
• Study First Posted: 2022-01-10
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
microscopic ear surgery group(MES)	microscopic ear surgery	-
endoscopic ear surgery group(EES)	endoscopic ear surgery	-

Primary Outcome Measures

Name	Time	Method
Pure Tone Average(PTA)	at least 1 year	estimate the auditory acuity
Air-Bone Gap(A-B Gap)	at least 1 year	estimate the auditory acuity