An interventional study of Lateral pharyngoplasty and Tonsillectomy in Sleep-Disordered Breathing, Sleep Apnea Syndromes in Children and Sleep Apnea, Obstructive, sponsored by Loma Linda University. Recruiting at 4 sites in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
The goal of this treatment study is to determine if doing lateral pharyngoplasty with tonsillectomy is better for children than doing tonsillectomy alone. The main questions it aims to answer are:
This is a randomized controlled trial to elucidate the benefits of performing lateral pharyngoplasty with tonsillectomy and encourage its use as a standard of care procedure. Participants will be randomized to receive either tonsillectomy +/- adenoidectomy or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention), with lateral pharyngoplasty referring to the placement two figure-of-8 sutures with 3-0 vicryl to reapproximate the anterior and posterior tonsillar pillars on each side. The investigators' hypothesis is that participants undergoing lateral pharyngoplasty will experience less pain, lower post-tonsillectomy hemorrhage rate, and a faster return to normal oral intake than participants undergoing tonsillectomy alone.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 160 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Loma Linda University is the lead sponsor of 306 studies on the registry; 46 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
Compared within Sleep Apnea, Obstructive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sleep Apnea Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.
Procedure: Tonsillectomy
Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.
Procedure: Lateral pharyngoplasty · Procedure: Tonsillectomy
Two figure-of-8 sutures using 3-0 vicryl are used to approximate the anterior and posterior tonsillar pillars and reconstruct the continuous mucosal covering of the lateral pharyngeal walls.
Extracapsular tonsillectomy
Level of post-operative pain
Will use the Wong-Baker FACES pain scale, which shows a series of faces ranging from a happy face at 0 (representing no pain) to a crying face at 10 (representing the worst pain imaginable). Parent/caregiver will document the pain score and pain medication administrations/duration of use.
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention
Count of subjects who undergo control of post-tonsillectomy hemorrhage in the operating room
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention
Count of subject/caregiver reports or presentations to a healthcare facility due to a post-tonsillectomy hemorrhage event that does not require control of hemorrhage in the operating room
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Post-operative duration (in days) to normal oral intake
Parent/caregiver's will estimate the participant's daily soft diet oral intake as a percentage of perceived baseline/normal
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Number of participants requiring intravenous fluid administration for dehydration
Presentation to healthcare facility due to lack of/perceived inadequate oral intake or decreased urination requiring intravenous fluid administration
Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery
Plan to share: No
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