Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT01319058
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2011-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome of Laser or Debrider Tonsillotomy Versus Tonsillectomy in Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014068', 'term': 'Tonsillectomy'}], 'ancestors': [{'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-15', 'studyFirstSubmitDate': '2011-03-17', 'studyFirstSubmitQcDate': '2011-03-18', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnea', 'Tonsillectomy', 'Tonsillotomy', 'Inflammation', 'Pain', 'Post tonsillectomy bleeding'], 'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '14746381', 'type': 'BACKGROUND', 'citation': 'Friedman BC, Hendeles-Amitai A, Kozminsky E, Leiberman A, Friger M, Tarasiuk A, Tal A. Adenotonsillectomy improves neurocognitive function in children with obstructive sleep apnea syndrome. Sleep. 2003 Dec 15;26(8):999-1005. doi: 10.1093/sleep/26.8.999.'}, {'pmid': '19539380', 'type': 'BACKGROUND', 'citation': 'Ericsson E, Lundeborg I, Hultcrantz E. Child behavior and quality of life before and after tonsillotomy versus tonsillectomy. Int J Pediatr Otorhinolaryngol. 2009 Sep;73(9):1254-62. doi: 10.1016/j.ijporl.2009.05.015. Epub 2009 Jun 17.'}, {'pmid': '16374970', 'type': 'BACKGROUND', 'citation': 'Anand A, Vilela RJ, Guarisco JL. Intracapsular versus standard tonsillectomy: review of literature. J La State Med Soc. 2005 Sep-Oct;157(5):259-61.'}, {'pmid': '32347984', 'type': 'DERIVED', 'citation': 'Blackshaw H, Springford LR, Zhang LY, Wang B, Venekamp RP, Schilder AG. Tonsillectomy versus tonsillotomy for obstructive sleep-disordered breathing in children. Cochrane Database Syst Rev. 2020 Apr 29;4(4):CD011365. doi: 10.1002/14651858.CD011365.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines.\n\nthe goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils.', 'detailedDescription': 'Tonsil surgery for children suffering from obstructive sleep apnea have significant post operative morbidity including pain and occasionally bleeding. This morbidity is partly caused by post surgical inflammation. This inflammatory process can be quantified using various proinflammatory cytokines.\n\nthe goal of this study is to objectively compare the inflammatory process after treatment of obstructive sleep apnea with different surgical approaches to the enlarged tonsils.\n\nIn the study three approaches are prospectively compared:\n\n1. Tonsillectomy - using electrocautery resecting all tonsillar tissue.\n2. Debrider Tonsillotomy - reducing the tonsillar tissue with a debrider.\n3. laser Tonsillotomy - reducing tonsillar tissue using a CO2 laser.\n\nAll patients will be randomized to one of three arms. Each arm will include 25 children.\n\nAll children will have a preoperative and postoperative sleep study. Questioners assessing pain, amount of medication used to control pain and sleep disturbance during the first 7 days after surgery will be filled by the child caretaker.\n\nBlood will be drawn immediately before surgery and 18-24 hours after surgery. The following blood products will be assessed: White blood cells, clotting factors, C reactive protein, IL1 beta,TNF alpha, IL6, IL2.\n\nIf the study will show objectively and subjectively that partial resection of the tonsil compared to complete tonsillectomy is less painful and has less postoperative inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nage 2-16 obstructive sleep apnea AHI\\>5 Hypertrophy of tonsils and adenoids\n\n\\-\n\nExclusion Criteria:\n\nChildren with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome'}, 'identificationModule': {'nctId': 'NCT01319058', 'acronym': 'TVLOD', 'briefTitle': 'Outcome of Laser or Debrider Tonsillotomy Versus Tonsillectomy in Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Laser or Debrider Tonsillotomy Versus Monopolar Tonsillectomy in Obstructive Sleep Apnea; Inflammation as a Determinate of Outcome', 'orgStudyIdInfo': {'id': 'sor495810ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Electrocautery tonsillectomy', 'description': 'Children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea', 'interventionNames': ['Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Debrider tonsillotomy', 'description': 'Children undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea.', 'interventionNames': ['Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laser tonsillotomy', 'description': 'Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea.', 'interventionNames': ['Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy']}], 'interventions': [{'name': 'Tonsillectomy, laser tonsillotomy, debrider tonsillotomy', 'type': 'PROCEDURE', 'description': 'Each arm will be treated by one of the three methods in addition to adenoidectomy', 'armGroupLabels': ['Debrider tonsillotomy', 'Electrocautery tonsillectomy', 'Laser tonsillotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Hospital', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Marc M Puterman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}, {'name': 'Aviv D Goldbart, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Soroka University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ben-Zion Joshua', 'investigatorAffiliation': 'Soroka University Medical Center'}}}}