Tokyo, June 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062052) titled 'Cholesteatoma Registry for Surgical Strategy - Japan' on June 25.

Study Type: Observational

Primary Sponsor: Institute - University of Toyama

Condition: Condition - Middle ear cholesteatoma Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to establish a nationwide prospective registry of patients undergoing primary surgery for newly diagnosed middle ear cholesteatoma and to evaluate their long-term postoperative outcomes for up to 10 years. The study aims to clarify postoperative recurrence rates, hearing outcomes, changes in quality of life, and associations between disease classification, surgical procedures, and prognosis. The findings are expected to contribute to the establishment of optimal standard surgical strategies for middle ear cholesteatoma based on the JOS classification. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients newly diagnosed with middle ear cholesteatoma. Patients whose cholesteatoma is classified as pars flaccida cholesteatoma, pars tensa cholesteatoma, secondary cholesteatoma, or congenital cholesteatoma. Patients who undergo primary surgery for middle ear cholesteatoma during the study registration period. Patients for whom written informed consent for participation in this study is obtained from the patient or a legally acceptable representative. Patients treated at institutions certified as otologic surgery training facilities by the Japan Otological Society. No restrictions are placed on age or sex. Key exclusion criteria - Patients with a history of previous surgery for middle ear cholesteatoma. Patients judged to be unable to undergo long-term postoperative follow-up for up to 10 years. Patients whose disease status is unclear and cannot be classified into the predefined disease types. Patients who do not provide consent for participation in this study or who withdraw consent. Target Size - 8000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 25 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2039 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070999

Disclaimer: Curated by HT Syndication.