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

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.

Study Overview

• Status: Completed
• Conditions: Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect
• Intervention / Treatment: Procedure: endoscopic ear surgery; Procedure: microscopic ear surgery

• Study Type: Observational
• Enrollment (Actual): 186

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

1. Patients who postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement. The extent of disease was confirmed by preoperative HRCT temporal bone.
2. The patients undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery.
3. have completely clinical characteristics, follow-up data and/or postoperative audiometric data

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
endoscopic ear surgery group(EES)	Procedure: endoscopic ear surgery; a ear surgery via endoscopic
microscopic ear surgery group(MES)	Procedure: microscopic ear surgery; a ear surgery via microscopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pure Tone Average(PTA)	estimate the auditory acuity	at least 1 year
Air-Bone Gap(A-B Gap)	estimate the auditory acuity	at least 1 year

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Keratosis; Cholesteatoma
• Other Study ID Numbers: SunYatsenU2H_YangH01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No