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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.
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.
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrocautery tonsillectomy | Active Comparator | Children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea |
|
| Debrider tonsillotomy | Active Comparator | Children undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea. |
|
| Laser tonsillotomy | Active Comparator | Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tonsillectomy, laser tonsillotomy, debrider tonsillotomy | Procedure | Each arm will be treated by one of the three methods in addition to adenoidectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance. | 12 months |
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Inclusion Criteria:
age 2-16 obstructive sleep apnea AHI>5 Hypertrophy of tonsils and adenoids
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Exclusion Criteria:
Children with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Marc M Puterman, MD | Soroka University Medical Center | Principal Investigator |
| Aviv D Goldbart, MD | Soroka University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Hospital | Beersheba | 84101 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14746381 | Background | 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. | |
| 19539380 | Background | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007249 | Inflammation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014068 | Tonsillectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 16374970 | Background | 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. |
| 32347984 | Derived | 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. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |