Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
Study NCT ID:
NCT05182268
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2021-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002781', 'term': 'Cholesteatoma'}], 'ancestors': [{'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-05', 'studyFirstSubmitDate': '2021-12-21', 'studyFirstSubmitQcDate': '2022-01-05', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pure Tone Average(PTA)', 'timeFrame': 'at least 1 year', 'description': 'estimate the auditory acuity'}, {'measure': 'Air-Bone Gap(A-B Gap)', 'timeFrame': 'at least 1 year', 'description': 'estimate the auditory acuity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect']}, 'descriptionModule': {'briefSummary': '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.\n\nMaterials 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. Patients who postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement. The extent of disease was confirmed by preoperative HRCT temporal bone.\n2. The patients undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery.\n3. have completely clinical characteristics, follow-up data and/or postoperative audiometric data', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement\n* the extent of disease was confirmed by preoperative HRCT temporal bone\n* undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery\n\nExclusion Criteria:\n\n* were lacking in clinical characteristics\n* had not preoperative audiometric data\n* missed the follow-up data\n* were lacking in surgical times\n* were microscopic combined endoscopic ear surgery'}, 'identificationModule': {'nctId': 'NCT05182268', 'briefTitle': 'Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study', 'orgStudyIdInfo': {'id': 'SunYatsenU2H_YangH01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'endoscopic ear surgery group(EES)', 'interventionNames': ['Procedure: endoscopic ear surgery']}, {'label': 'microscopic ear surgery group(MES)', 'interventionNames': ['Procedure: microscopic ear surgery']}], 'interventions': [{'name': 'endoscopic ear surgery', 'type': 'PROCEDURE', 'description': 'a ear surgery via endoscopic', 'armGroupLabels': ['endoscopic ear surgery group(EES)']}, {'name': 'microscopic ear surgery', 'type': 'PROCEDURE', 'description': 'a ear surgery via microscopic', 'armGroupLabels': ['microscopic ear surgery group(MES)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}