Outcome of Laser or Debrider Tonsillotomy Versus Tonsillectomy in Obstructive Sleep Apnea
NCT ID: NCT01319058
Last Updated: 2016-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2010-08-31
2013-07-31
Brief Summary
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the 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.
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Detailed Description
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the 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.
In the study three approaches are prospectively compared:
1. Tonsillectomy - using electrocautery resecting all tonsillar tissue.
2. Debrider Tonsillotomy - reducing the tonsillar tissue with a debrider.
3. laser Tonsillotomy - reducing tonsillar tissue using a CO2 laser.
All patients will be randomized to one of three arms. Each arm will include 25 children.
All 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.
Blood 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.
If 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Electrocautery tonsillectomy
Children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea
Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
Each arm will be treated by one of the three methods in addition to adenoidectomy
Debrider tonsillotomy
Children undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea.
Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
Each arm will be treated by one of the three methods in addition to adenoidectomy
Laser tonsillotomy
Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea.
Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
Each arm will be treated by one of the three methods in addition to adenoidectomy
Interventions
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Tonsillectomy, laser tonsillotomy, debrider tonsillotomy
Each arm will be treated by one of the three methods in addition to adenoidectomy
Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
2 Years
16 Years
ALL
No
Sponsors
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Soroka University Medical Center
OTHER
Responsible Party
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Ben-Zion Joshua
MD
Principal Investigators
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Marc M Puterman, MD
Role: PRINCIPAL_INVESTIGATOR
Soroka University Medical Center
Aviv D Goldbart, MD
Role: STUDY_DIRECTOR
Soroka University Medical Center
Locations
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Soroka Hospital
Beersheba, , Israel
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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sor495810ctil
Identifier Type: -
Identifier Source: org_study_id
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