Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT00519402
Status:
WITHDRAWN
Last Update Posted:
2017-11-13
First Post:
2007-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001049', 'term': 'Apnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'lastUpdateSubmitDate': '2017-11-08', 'studyFirstSubmitDate': '2007-08-21', 'studyFirstSubmitQcDate': '2007-08-21', 'lastUpdatePostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['partial tonsillectomy', 'complete tonsillectomy', 'tonsillectomy', 'obstruction sleep disordered breathing OSDB', 'apnea'], 'conditions': ['Obstructive Sleep Disordered Breathing']}, 'descriptionModule': {'briefSummary': 'Introduction: There is currently no long-term study, which compares the outcomes of partial tonsillectomy to conventional tonsillectomy. We hypothesize that there will be little significant tonsillar regrowth with partial tonsillectomy.\n\nBackground and Significance: Tonsillectomy is the most common major surgical procedure performed on children in the United States with nearly 300,000 procedures performed each year, primarily for the indication of obstructive sleep disordered breathing (OSDB). Conventional (total) tonsillectomy removes the tonsillar capsule, and partial tonsillectomy preserves the capsule by shaving away the tonsils using an endoscopic microdebrider. Partial tonsillectomy results in less pain, fewer days to normal activity and diet, and fewer days of analgesics than total tonsillectomy. There are no significant differences between the techniques in blood loss or postoperative life improved Historical evidence suggests that eventually there will be tonsillar regrowth with partial tonsillectomy. However, in a 2003 follow-up report of 243 children undergoing partial tonsillectomy and 107 undergoing complete tonsillectomy from 1998 through 2002 for OSDB there was no evidence of significant tonsillar regrowth. (1) We will follow-up children undergoing partial or complete tonsillectomies at the Cleveland Clinic from 1998 through 2002. There will be standardized tonsillar examinations by two observers, with a third observer in cases of significant disagreement, and questionnaires evaluating sleep apnea and daytime sleepiness, and number of tonsillar infections.\n\nIf there are a large number of children with recurrent tonsillar symptoms post partial tonsillectomy, the procedure should be abandoned. However, if follow-up reveals comparable tonsillar symptoms for partial and the total tonsillectomy, perhaps the partial procedure should replace the total tonsillectomy as the standard operation to relieve tonsillar OSDB. This could eventually result in millions of less lost days of work and school in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '28 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients undergoing tonsillectomies at the Cleveland Clinic from 1998-2002', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients undergoing tonsillectomies at the Cleveland Clinic from 1998-2002'}, 'identificationModule': {'nctId': 'NCT00519402', 'briefTitle': 'Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing in Children', 'orgStudyIdInfo': {'id': '07-433'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Partial Tonsillectomy', 'description': 'Patients who received a partial tonsillectomy', 'interventionNames': ['Other: tonsillar examination and questionnaire completion']}, {'label': 'Complete Tonsillectomy', 'description': 'Patients who received a complete tonsillectomy', 'interventionNames': ['Other: tonsillar examination and questionnaire completion']}], 'interventions': [{'name': 'tonsillar examination and questionnaire completion', 'type': 'OTHER', 'armGroupLabels': ['Complete Tonsillectomy', 'Partial Tonsillectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Michael L Macknin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff, General Pediatrics', 'investigatorFullName': 'michael macknin', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}