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Clinical Trials/NCT05182268
NCT05182268
Completed
Not Applicable

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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University0 sites186 target enrollmentNovember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment
186
Primary Endpoint
Pure Tone Average(PTA)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2016
End Date
March 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pure Tone Average(PTA)

Time Frame: at least 1 year

estimate the auditory acuity

Air-Bone Gap(A-B Gap)

Time Frame: at least 1 year

estimate the auditory acuity

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