NCT05575401 Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
| NCT ID | NCT05575401 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Loma Linda University |
| Condition | Sleep-Disordered Breathing |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2023-05-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2023-05-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Tsungju O-Lee, MD
PRINCIPAL INVESTIGATOR
Loma Linda University Health
Frequently Asked Questions
Who can join the NCT05575401 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Sleep-Disordered Breathing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05575401 currently recruiting?
Yes, NCT05575401 is actively recruiting participants. Contact the research team at scalaguas@llu.edu for enrollment information.
Where is the NCT05575401 trial being conducted?
This trial is being conducted at Murrieta, United States, Riverside, United States, San Bernardino, United States, San Bernardino, United States.
Who is sponsoring the NCT05575401 clinical trial?
NCT05575401 is sponsored by Loma Linda University. The principal investigator is Tsungju O-Lee, MD at Loma Linda University Health. The trial plans to enroll 160 participants.