ATT Compared With ATE in OSAS Children

NCT ID: NCT01676181

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2017-03-31

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.

Conditions

Obstructive Sleep Apnea Syndrome in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Adenotonsillectomy

Total removal of tonsils and adenoids with cold steel

Group Type: ACTIVE_COMPARATOR

Adenotonsillectomy

Intervention Type: PROCEDURE

Total removal of tonsils and adenoid tissue with cold-steel

Adenotonsillotomy

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

Group Type: ACTIVE_COMPARATOR

Adenotonsillotomy

Intervention Type: PROCEDURE

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

Interventions

Adenotonsillectomy

Total removal of tonsils and adenoid tissue with cold-steel

Intervention Type: PROCEDURE

Adenotonsillotomy

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Danielle Friberg

Associate Professor, senior surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danielle Friberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital, ORL dep

Locations

Karolinska University Hospital, ORL dep

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 32347984 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31377901 (View on PubMed)

Other Identifiers

2011/333-31/4

Identifier Type: -

Identifier Source: org_study_id