ATT Compared With ATE in OSAS Children (RCT ATE/ATT)

Karolinska University Hospital

Status: Completed

Conditions: Obstructive Sleep Apnea Syndrome in Children

Treatments: Procedure: Adenotonsillectomy; Procedure: Adenotonsillotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01676181

2011/333-31/4

Details and patient eligibility

About

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

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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79 participants in 2 patient groups

Adenotonsillectomy

Active Comparator group

Description:

Total removal of tonsils and adenoids with cold steel

Treatment:

Procedure: Adenotonsillectomy

Adenotonsillotomy

Active Comparator group

Description:

Partial removal of tonsils with coblation and total removal of adenoids with cold steel

Treatment:

Procedure: Adenotonsillotomy