RecruitingNot ApplicableNCT05575401

Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

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


Sponsor

Loma Linda University

Enrollment

160 participants

Start Date

May 17, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 17 Years

Inclusion Criteria1

  • Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health

Exclusion Criteria4

  • Subjects with congenital syndromes and/or developmental delay
  • Subjects with cancer
  • Subjects with gastrostomy tube use or dependence
  • Subjects undergoing intracapsular tonsillectomy

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Interventions

PROCEDURELateral pharyngoplasty

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.

PROCEDURETonsillectomy

Extracapsular tonsillectomy


Locations(4)

Loma Linda University Professional Building - Murrieta

Murrieta, California, United States

Loma Linda University ENT/Head & Neck Surgery

Riverside, California, United States

Pediatric Ear, Nose, and Throat Surgery and Audiology

San Bernardino, California, United States

SAC Health - ENT Clinic

San Bernardino, California, United States

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NCT05575401


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