ATT Compared With ATE in OSAS Children
Condition: Obstructive Sleep Apnea Syndrome in Children
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Adenotonsillectomy; Adenotonsillotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Total removal of tonsils and adenoid tissue with cold-steel; Partial removal of tonsils with coblation and total removal of adenoids with cold steel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea syndrome; Children; Polysomnography; Surgery; Coblation; Tonsils; Tonsillectomy