OBJECTIVE: To compare the efficacy of adenotonsillectomy (T&A) with and without pharyngoplasty (tonsillar pillar closure) in the treatment of pediatric obstructive sleep apnea-hypopnea syndrome (OSAHS). STUDY DESIGN: Randomized single-blind controlled study. SETTING: Tertiary care center. SUBJECTS AND METHODS: Sixty pediatric patients with a clinical diagnosis of OSAHS presenting between January 2009 and December 2010 were enrolled and randomized to undergo either standard T&A (n = 30) or T&A with pharyngoplasty (n = 30). Surgical cure was defined as apnea-hypopnea index (AHI) <5 plus OSA-18 health-related quality-of-life (HRQL) score <60. Other outcomes included postsurgical AHI and minimum oxygen saturation (SpO(2)) improvement, changes in OSA-18 scores at 1 month, and postsurgical days to resume normal diet and activity. RESULTS: Three patients from each group did not undergo surgery. Of the 54 patients treated, 8 from the pharyngoplasty group and 2 from the standard group were lost to follow-up. Intention-to-treat analysis revealed no difference in cure rate between groups (standard 60%, pharyngoplasty 56.6%, P = .793). Limiting analysis to those patients with complete data, a higher, but not significantly increased, cure rate with pharyngoplasty was noted (72% vs 89.5%, P = .155). Greater OSA-18 improvement (P = .036) and greater (although nonsignificant) AHI improvement and earlier return to normal function were noted with pharyngoplasty. CONCLUSION: The addition of pharyngoplasty to traditional adenotonsillectomy did not significantly improve OSAHS cure rates as measured by sleep testing and HRQL, although a nonsignificant increase in cure rate was observed in those who completed the study protocol. An unexpectedly high rate of patient dropout rendered the study statistically underpowered and therefore inconclusive.
RCT Entities:
OBJECTIVE: To compare the efficacy of adenotonsillectomy (T&A) with and without pharyngoplasty (tonsillar pillar closure) in the treatment of pediatric obstructive sleep apnea-hypopnea syndrome (OSAHS). STUDY DESIGN: Randomized single-blind controlled study. SETTING: Tertiary care center. SUBJECTS AND METHODS: Sixty pediatric patients with a clinical diagnosis of OSAHS presenting between January 2009 and December 2010 were enrolled and randomized to undergo either standard T&A (n = 30) or T&A with pharyngoplasty (n = 30). Surgical cure was defined as apnea-hypopnea index (AHI) <5 plus OSA-18 health-related quality-of-life (HRQL) score <60. Other outcomes included postsurgical AHI and minimum oxygen saturation (SpO(2)) improvement, changes in OSA-18 scores at 1 month, and postsurgical days to resume normal diet and activity. RESULTS: Three patients from each group did not undergo surgery. Of the 54 patients treated, 8 from the pharyngoplasty group and 2 from the standard group were lost to follow-up. Intention-to-treat analysis revealed no difference in cure rate between groups (standard 60%, pharyngoplasty 56.6%, P = .793). Limiting analysis to those patients with complete data, a higher, but not significantly increased, cure rate with pharyngoplasty was noted (72% vs 89.5%, P = .155). Greater OSA-18 improvement (P = .036) and greater (although nonsignificant) AHI improvement and earlier return to normal function were noted with pharyngoplasty. CONCLUSION: The addition of pharyngoplasty to traditional adenotonsillectomy did not significantly improve OSAHS cure rates as measured by sleep testing and HRQL, although a nonsignificant increase in cure rate was observed in those who completed the study protocol. An unexpectedly high rate of patient dropout rendered the study statistically underpowered and therefore inconclusive.
Authors: Wojciech Kukwa; Andrzej Kukwa; Adam Galazka; Anna M Czarnecka; Antoni Krzeski; Ewa Migacz; Stacey L Ishman Journal: Sleep Breath Date: 2015-03-06 Impact factor: 2.816
Authors: Noura A Alsufyani; Michelle L Noga; Manisha Witmans; Irene Cheng; Hamdy El-Hakim; Paul W Major Journal: J Otolaryngol Head Neck Surg Date: 2017-04-11