ATT Compared With ATE in OSAS Children

Study Overview
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Brief Summary
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Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.

Detailed Description
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Background: Children with obstructive sleep apnea syndrome (OSAS) have apneas and disturbed sleep, which causes daytime symptoms such as neurobehavioral problems. OSAS is a significant cause of morbidity among children with an incidence of 1-3%, and a peak prevalence at 2-5 years of age. If left untreated it can cause severe complications including failure to thrive, cardiovascular complications, metabolic conditions and neurobehavioral disturbances (eg hyperactivity, inattention). Golden standard to diagnose OSA in children is full-night polysomnography (PSG) at a sleep laboratory including EEG, EOG, EMG, video-audiometry and respiratory recordings. At the Department of Otorhinolaryngology at Karolinska University Hospital, we have a sleep laboratory performing in-lab full-night polysomnography. The cause of OSAS in children is usually adenotonsillar hypertrophy, and the treatment of choice is surgical removal of tonsils and adenoid. Traditionally total adenotonsillectomy (ATE) has been performed, but in the last decade an alternative surgical method with partial adenotonsillotomy (ATT) is developed, where only the medial portion of the tonsil is removed. The newer method ATT is not fully evaluated in comparison with traditional ATE. There are studies comparing evaluating post-operative pain and bleeding showing a slight advantage for the TT-method. Very few studies are performed using objectively measured PSG-parameters to evaluate the effect of surgery on the sleep fragmentation and the sleep apneas. There is a need for such studies in the field of surgical treatment of pediatric OSA. This was also stated in a Cochrane database review from 2009, in which the conclusion was that there is a need for high quality randomised controlled trials to be carried out investigating the efficacy of surgical treatment of OSA in children. This makes this study important and of high clinical interest. Aims: To increase the knowledge of pediatric OSA and its treatment and to optimize the surgical treatment for children with OSA. To through a blinded randomized controlled trial compare the efficacy of ATT and ATE in treating OSA in children, including long-term follow-up after one, three and ten years. To evaluate postoperative pain after ATE and ATT. To evaluate quality of life after ATE and ATT.

Official Title
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Randomised Surgical Intervention Study Between Adenotonsillectomy and Adenotonsillotomy in Children With Obstructive Sleep Apnea Syndrome

Conditions
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Obstructive Sleep Apnea Syndrome in Children

Intervention / Treatment
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* Procedure: Adenotonsillectomy
* Procedure: Adenotonsillotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 2-6 years Clinical symptoms of OSAS (apneas, snoring, disturbed sleep) Tonsil size 3-4 with the Brodsky scale (obstructing at least 50% of the oro-pharyngeal space) Apnea-Hypopnea Index (AHI) 5-30 (moderate- severe OSA) Exclusion Criteria: Clinical signs of craniofacial anomalies or neuromuscular disorders Obesity Earlier having had surgery of tonsils or adenoid Bleeding disorder Cardiopulmonary disorder

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adenotonsillectomy<br>Total removal of tonsils and adenoids with cold steel | Procedure: Adenotonsillectomy<br>* Total removal of tonsils and adenoid tissue with cold-steel<br>|
| Active Comparator: Adenotonsillotomy<br>Partial removal of tonsils with coblation and total removal of adenoids with cold steel | Procedure: Adenotonsillotomy<br>* Partial removal of tonsils with coblation and total removal of adenoids with cold steel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in polysomnographic parameter AHI (Apnea Hypopnea Index) | AHI; the number of apneas and hypopneas per sleep hour, is measured through polysomnography before and after surgery. | One, three and ten years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality of life questionnaires (OSA18 and SDQ) | Parents answering to quality of life-questionnaire OSA18 and SDQ (Strengths and Difficulties Questionnaire) before and after surgical intervention | One, three and ten Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea syndrome, Children, Polysomnography, Surgery, Coblation, Tonsils, Tonsillectomy