RECRUITING

Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-17
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05575401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health
  1. * Subjects with congenital syndromes and/or developmental delay
  2. * Subjects with cancer
  3. * Subjects with gastrostomy tube use or dependence
  4. * Subjects undergoing intracapsular tonsillectomy

Contacts and Locations

Study Contact

Shannon Calaguas, MD
CONTACT
(909) 558-8558
scalaguas@llu.edu
Ethan Frank, MD
CONTACT
(909) 558-8558
efrank@llu.edu

Principal Investigator

Tsungju O-Lee, MD
PRINCIPAL_INVESTIGATOR
Loma Linda University Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Loma Linda University

  • Tsungju O-Lee, MD, PRINCIPAL_INVESTIGATOR, Loma Linda University Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-17
Study Completion Date2025-08

Study Record Updates

Study Start Date2023-05-17
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Tonsillectomy
  • Post-tonsillectomy hemorrhage
  • Post-tonsillectomy complication
  • Lateral pharyngoplasty

Additional Relevant MeSH Terms

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