Clinical trial NCT01676181: ATT Compared With ATE in OSAS Children
Official title: Randomised Surgical Intervention Study Between Adenotonsillectomy and Adenotonsillotomy in Children With Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome in Children
Keywords: Obstructive sleep apnea syndrome
Children
Polysomnography
Surgery
Coblation
Tonsils
Tonsillectomy
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 79
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in polysomnographic parameter AHI (Apnea Hypopnea Index)
timeFrame: One, three and ten years
Secondary outcomes:
measure: Changes in quality of life questionnaires (OSA18 and SDQ)
timeFrame: One, three and ten Years
Other outcomes:
measure: Per- and postoperative bleeding
timeFrame: One year
measure: changes in polysomnographic parameters other than AHI
timeFrame: one, three and ten years
measure: Differences in postoperative pain
timeFrame: One year
measure: Number of patients who need reoperations
timeFrame: One, three and ten years
measure: Abnormalities in DNA analysis of blood and tonsil tissue
timeFrame: one year
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, ORL dep
Study officials:
affiliation: Karolinska University Hospital, ORL dep
name: Danielle Friberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Borgstrom A, Nerfeldt P, Friberg D. Postoperative pain and bleeding after adenotonsillectomy versus adenotonsillotomy in pediatric obstructive sleep apnea: an RCT. Eur Arch Otorhinolaryngol. 2019 Nov;276(11):3231-3238. doi: 10.1007/s00405-019-05571-w. Epub 2019 Aug 3.