Anna Borgström1, Pia Nerfeldt2, Danielle Friberg2. 1. Department of Otorhinolaryngology, Karolinska University Hospital, and Department of Clinical Science, Intervention and Technology, CLINTEC, Karolinska Institute, Stockholm, Sweden anna.borgstrom@karolinska.se. 2. Department of Otorhinolaryngology, Karolinska University Hospital, and Department of Clinical Science, Intervention and Technology, CLINTEC, Karolinska Institute, Stockholm, Sweden.
Abstract
BACKGROUND:Adenotonsillectomy (ATE) is a well-established and effective treatment of pediatric obstructive sleep apnea (OSA). In recent years, a more conservative method, adenotonsillotomy (ATT), has gained popularity because it is associated with less postoperative morbidity. Yet no previous randomized study has compared these 2 methods regarding their effectiveness in treating pediatric OSA in terms of polysomnographic data, which was the primary aim of this study. The hypothesis was that ATT is noninferior to ATE after 1 year. METHODS:Seventy-nine children, aged 2 to 6 years, with OSA (Apnea-Hypopnea Index [AHI] 5-30) were randomized to ATT (n = 40) or ATE (n = 39). Polysomnography (PSG) and questionnaire OSA-18 were assessed at baseline and 1 year postsurgery. RESULTS: Mean difference between groups in the primary outcome, change in AHI, was 0.83, 95% confidence interval -3.2 to 4.9, not exceeding the noninferiority margin of 5. After ATE, AHI decreased from median 12.7 (interquartile range 8.3-19.1) to 2.0 (1.2-3.1) and after ATT from 15.8 (8.5-21.2) to 4.0 (1.2-5.1). For both groups, significant improvements of PSG and OSA-18questionnaire outcomes were observed, with no significant differences between groups. Five children (13%) in the ATT group needed repeated surgery for tonsil regrowth and recurrence of OSA. CONCLUSIONS: The results suggest that ATT is noninferior to ATE in treating pediatric OSA regarding PSG outcomes after 1 year. ATT could be considered an alternative to ATE for treatment of pediatric OSA. However, after ATT, there is a nonnegligible risk of recurrence of OSA, and this should be taken into account when selecting surgical method.
RCT Entities:
BACKGROUND: Adenotonsillectomy (ATE) is a well-established and effective treatment of pediatric obstructive sleep apnea (OSA). In recent years, a more conservative method, adenotonsillotomy (ATT), has gained popularity because it is associated with less postoperative morbidity. Yet no previous randomized study has compared these 2 methods regarding their effectiveness in treating pediatric OSA in terms of polysomnographic data, which was the primary aim of this study. The hypothesis was that ATT is noninferior to ATE after 1 year. METHODS: Seventy-nine children, aged 2 to 6 years, with OSA (Apnea-Hypopnea Index [AHI] 5-30) were randomized to ATT (n = 40) or ATE (n = 39). Polysomnography (PSG) and questionnaire OSA-18 were assessed at baseline and 1 year postsurgery. RESULTS: Mean difference between groups in the primary outcome, change in AHI, was 0.83, 95% confidence interval -3.2 to 4.9, not exceeding the noninferiority margin of 5. After ATE, AHI decreased from median 12.7 (interquartile range 8.3-19.1) to 2.0 (1.2-3.1) and after ATT from 15.8 (8.5-21.2) to 4.0 (1.2-5.1). For both groups, significant improvements of PSG and OSA-18 questionnaire outcomes were observed, with no significant differences between groups. Five children (13%) in the ATT group needed repeated surgery for tonsil regrowth and recurrence of OSA. CONCLUSIONS: The results suggest that ATT is noninferior to ATE in treating pediatric OSA regarding PSG outcomes after 1 year. ATT could be considered an alternative to ATE for treatment of pediatric OSA. However, after ATT, there is a nonnegligible risk of recurrence of OSA, and this should be taken into account when selecting surgical method.