Adenopharyngoplasty vs Adenotonsillectomy in Children With Severe Obstructive Sleep Apnea: A Randomized Clinical Trial

Abstract

Importance: Adenotonsillectomy (ATE) is the primary surgical method for treating obstructive sleep apnea (OSA) in children. However, children with severe OSA have an increased risk for residual OSA after ATE. Previous studies indicate that adenopharyngoplasty (APP), a modified ATE with closure of the tonsillar pillars, might improve the surgical outcome, but the overall evidence is weak.

Objective: To determine whether APP is more effective than ATE for treating severe OSA in otherwise healthy children.

Design, setting, and participants: A blinded randomized clinical trial was conducted at the otorhinolaryngology department at Karolinska University Hospital, Stockholm, Sweden. Eighty-three children, aged 2 to 4 years, with an obstructive apnea-hypopnea index (OAHI) score of 10 or higher, were randomized to APP (n = 36) or ATE (n = 47). Participants were recruited from December 1, 2014, through November 31, 2016.

Interventions: Adenotonsillectomy was performed in all 83 patients in both groups by the cold steel technique. The APP group also underwent closure of the tonsillar pillars with 2 inverted sutures on each side.

Main outcomes and measures: The primary outcome was the difference between the groups in OAHI score change before and after surgery. A higher score indicates worse problems and a score of 10 or higher is defined as severe OSA. The outcome was evaluated per protocol and with intention-to-treat analysis. Secondary outcomes were other polysomnography variables and the Obstructive Sleep Apnea-18 (OSA-18) questionnaire (possible total symptom score range, 18-126; higher scores indicate worse quality of life). Polysomnography was performed and the OSA-18 questionnaire was completed preoperatively and 6 months postoperatively.

Results: A total of 83 children (49 [59%] boys; mean [SD] age, 36.6 [9.2] months) were included in the study. Of these, 74 (89%) (APP, n = 30; ATE, n = 44) completed the study. The mean (SD) preoperative OAHI score was 23.8 (11.8) for APP and 23.8 (11.5) for ATE. Both the APP and ATE groups had a significant decrease in mean OAHI score after surgery (-21.7; 95% CI, -26.3 to -17.2; and -21.1; 95% CI, -24.5 to -17.7, respectively), but there was no significant difference between the groups (0.7; 95% CI, -4.8 to 6.1). Furthermore, no significant differences between the groups were seen regarding other polysomnography variables (eg, respiratory distress index: mean, 0.6; 95% CI, -5.0 to 6.3) or the OSA-18 questionnaire (eg, total symptom score: -0.5; 95% CI, -13 to 12). One patient from each group was readmitted owing to postoperative bleeding, but no other complications were seen.

Conclusions and relevance: This trial did not show that APP was more effective than ATE alone to treat otherwise healthy children with severe OSA. This finding suggests that ATE should continue to be the primary treatment for OSA in children.

Trial registration: ClinicalTrials.gov Identifier: NCT02315911.

Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Figures

Figure 1.. Study Flowchart

APP indicates adenopharyngoplasty; ATE, adenotonsillectomy; and OSA, obstructive sleep apnea.

Figure 2.. Adenopharyngoplasty Technique

Closure of the tonsillar pillars after tonsillectomy, with 2 sutures on each side, including fibers of the palatopharyngeus muscle.

Figure 3.. Adenotonsillectomy (ATE) and Adenopharyngoplasty (APP) Group Outcomes

Outcomes of ATE (A) and APP (B). Boxes include the median and the first to third quartile. Whiskers are within the 1.5 interquartile range, and circles are outliers. Line graphs show individual baseline (preoperative) and follow-up (postoperative) obstructive apnea-hypopnea index (OAHI) scores (where a score of 10 or higher is considered severe OSA).