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OpenTrials
Completed

NCT Number: NCT05182268

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.

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Key information

Conditions

Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect Cholesteatoma Keratosis Skin Diseases Skin and Connective Tissue Diseases

Age range

6 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic ear surgery

Procedure

a ear surgery via endoscopic

microscopic ear surgery

Procedure

a ear surgery via microscopic

Primary outcomes

  1. Pure Tone Average(PTA)

    Time frame: at least 1 year

    estimate the auditory acuity

  2. Air-Bone Gap(A-B Gap)

    Time frame: at least 1 year

    estimate the auditory acuity

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jan 10, 2022
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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