Outcome of Laser or Debrider Tonsillotomy Versus Tonsillectomy in Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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.

Detailed Description
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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. In the study three approaches are prospectively compared: Tonsillectomy - using electrocautery resecting all tonsillar tissue. Debrider Tonsillotomy - reducing the tonsillar tissue with a debrider. 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.

Official Title
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Laser or Debrider Tonsillotomy Versus Monopolar Tonsillectomy in Obstructive Sleep Apnea; Inflammation as a Determinate of Outcome

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 2-16 obstructive sleep apnea AHI>5 Hypertrophy of tonsils and adenoids - Exclusion Criteria: Children with recurrent tonsillitis craniofacial anomalies Neuromuscular disease Down syndrome

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electrocautery tonsillectomy<br>Children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea | Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy<br>* Each arm will be treated by one of the three methods in addition to adenoidectomy<br>|
| Active Comparator: Debrider tonsillotomy<br>Children undergoing debrider tonsillotomy + adenoidectomy for obstructive sleep apnea. | Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy<br>* Each arm will be treated by one of the three methods in addition to adenoidectomy<br>|
| Active Comparator: Laser tonsillotomy<br>Children undergoing laser tonsillotomy + adenoidectomy for obstructive sleep apnea. | Procedure: Tonsillectomy, laser tonsillotomy, debrider tonsillotomy<br>* Each arm will be treated by one of the three methods in addition to adenoidectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the three arms regarding serum IL1 beta, TNF alpha, IL2, IL6. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the three arms regarding pain, post tonsillectomy bleeding and post operative sleep disturbance. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, Tonsillectomy, Tonsillotomy, Inflammation, Pain, Post tonsillectomy bleeding