Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

Study Overview
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Brief Summary
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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: Do children experience less pain after surgery when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone? Do children eat/drink better when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone? Is there a lower risk of bleeding after tonsillectomy when lateral pharyngoplasty is performed? Researchers will compare children undergoing tonsillectomy and lateral pharyngoplasty with children undergoing tonsillectomy alone to see if the participants experience less pain, better oral intake, and less bleeding complications after surgery. Parents of participants will be asked to record pain scores and pain medications given, approximate amounts of daily oral intake, and any complications after surgery.

Detailed Description
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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.

Official Title
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Post-operative Outcomes of Tonsillectomy With Lateral Pharyngoplasty Versus Tonsillectomy Alone in Children: a Randomized Controlled Trial

Conditions
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Sleep-Disordered Breathing, Sleep Apnea Syndromes in Children, Sleep Apnea, Obstructive, Tonsillitis, Tonsil Stone, Tonsillar Hypertrophy, Tonsil Disease

Intervention / Treatment
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* Procedure: Lateral pharyngoplasty
* Procedure: Tonsillectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health Exclusion Criteria: Subjects with congenital syndromes and/or developmental delay Subjects with cancer Subjects with gastrostomy tube use or dependence Subjects undergoing intracapsular tonsillectomy

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants ages 3-17 years undergoing tonsillectomy for any reason will be randomized to either undergo tonsillectomy +/- adenoidectomy (standard of care practice) or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention). Parents of participants in both arms will be given post-operative worksheets to document pain scores, pain medication administration, estimates of daily per os intake, and any complications.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tonsillectomy +/- adenoidectomy<br>Participants will undergo extracapsular tonsillectomy +/- adenoidectomy. | Procedure: Tonsillectomy<br>* Extracapsular tonsillectomy<br>|
| Experimental: Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty<br>Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty. | Procedure: Lateral pharyngoplasty<br>* 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.<br>Procedure: Tonsillectomy<br>* Extracapsular tonsillectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | Change between baseline (immediately post-op) through 6 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change between baseline (immediately post-op) through 6 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, Post-tonsillectomy hemorrhage, Post-tonsillectomy complication, Lateral pharyngoplasty