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

NCT05182268 | Completed

• 1 other identifier: SunYatsenU2H_YangH01
• Study Type: observational
• Target: 186
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

endoscopic ear surgery group(EES)

Procedure: endoscopic ear surgery

microscopic ear surgery group(MES)

Procedure: microscopic ear surgery

Interventions

endoscopic ear surgery PROCEDURE

a ear surgery via endoscopic

endoscopic ear surgery group(EES)

microscopic ear surgery PROCEDURE

a ear surgery via microscopic

microscopic ear surgery group(MES)

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Cholesteatoma

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 10, 2022
• Study Start: November 1, 2016
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: January 10, 2022

Record last verified: 2021-12