Comparing outcomes of lateral pharyngoplasty with tonsillectomy in children
Post-operative Outcomes of Tonsillectomy With Lateral Pharyngoplasty Versus Tonsillectomy Alone in Children: a Randomized Controlled Trial
This study tests if adding a throat surgery called lateral pharyngoplasty to tonsil removal helps children recover better and feel less pain after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Locations | 4 sites (Murrieta, California and 3 other locations) |
| Trial ID | NCT05575401 on ClinicalTrials.gov |
What this trial studies
This treatment study aims to evaluate the benefits of performing lateral pharyngoplasty alongside tonsillectomy in children aged 3-17. It will compare pain levels, oral intake, and bleeding complications between children undergoing the combined procedure and those receiving tonsillectomy alone. Participants will be randomized to receive either treatment, and their parents will track pain scores, medication use, and any complications post-surgery. The goal is to determine if lateral pharyngoplasty can improve recovery outcomes for children undergoing tonsillectomy.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-17 years who are scheduled for tonsillectomy with or without adenoidectomy.
Not a fit: Patients with congenital syndromes, developmental delays, cancer, or those requiring intracapsular tonsillectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced pain and complications for children undergoing tonsillectomy.
How similar studies have performed: While the specific combination of lateral pharyngoplasty with tonsillectomy is being evaluated, similar studies have shown promising results in improving surgical outcomes in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Murrieta, California and 3 other locations
- Loma Linda University Professional Building - Murrieta — Murrieta, California, United States (Not_yet_recruiting)
- Loma Linda University ENT/Head & Neck Surgery — Riverside, California, United States (Recruiting)
- Pediatric Ear, Nose, and Throat Surgery and Audiology — San Bernardino, California, United States (Not_yet_recruiting)
- SAC Health - ENT Clinic — San Bernardino, California, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Tsungju O-Lee, MD — Loma Linda University Health
- Study coordinator: Shannon Calaguas, MD
- Email: scalaguas@llu.edu
- Phone: (909) 558-8558
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.