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NCT05575401NARecruiting

Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

Loma Linda University

Start Date

5/17/2023

Completion Date

12/1/2026

Summary

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

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.

Eligibility Criteria

Age Range: 3 years to 17 years

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

Interventions

PROCEDURE

Lateral pharyngoplasty

PROCEDURE

Tonsillectomy

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Conditions

Sleep-Disordered BreathingSleep Apnea Syndromes in ChildrenSleep Apnea, ObstructiveTonsillitisTonsillar HypertrophyTonsil StoneTonsil Disease

Locations

Loma Linda University Professional Building - Murrieta

Murrieta, California 92563

United States

Loma Linda University ENT/Head & Neck Surgery

Riverside, California 92506

United States

Pediatric Ear, Nose, and Throat Surgery and Audiology

San Bernardino, California 92408

United States

SAC Health - ENT Clinic

San Bernardino, California 92410

United States