Actively Recruiting

Phase Not Applicable
Age: 3Years - 17Years
All Genders
ID05575401

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

Led by Loma Linda University · Updated on 2026-02-23

160

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding lateral pharyngoplasty to tonsillectomy provides better outcomes for children aged 3 to 17 years undergoing tonsillectomy with or without adenoidectomy. The study aims to find out if this combined procedure leads to less pain, improved eating and drinking after surgery, and a lower risk of bleeding complications compared to tonsillectomy alone. This randomized controlled trial seeks to establish lateral pharyngoplasty with tonsillectomy as a standard care option if benefits are confirmed. Participants will be randomly assigned to one of two groups: one group will have extracapsular tonsillectomy with or without adenoidectomy, while the other group will receive the same surgery plus lateral pharyngoplasty. The lateral pharyngoplasty involves placing two figure-of-8 sutures using 3-0 vicryl to bring together the anterior and posterior tonsillar pillars, reconstructing the mucosal covering of the lateral pharyngeal walls. The surgery and procedures will be performed under medical supervision as part of the trial. During the study, parents will help track their child's pain levels, use of pain medications, daily oral intake amounts, and any complications after surgery. Researchers will monitor participants from immediately after surgery through six weeks post-operation, focusing on pain levels, bleeding incidents that require or do not require surgical intervention, and the time it takes for the child to resume normal eating and drinking. This monitoring helps assess the safety and recovery experience between the two surgical approaches.

CONDITIONS

Brief Title

Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

Who Can Participate

Age: 3Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants ages 3 to 17 years undergoing tonsillectomy with or without adenoidectomy at Loma Linda University Health
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo tonsillectomy with or without adenoidectomy, with some also receiving lateral pharyngoplasty during surgery. Immediate recovery and monitoring occur after the procedure.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 6 weeks

Participants are monitored for post-operative pain, hemorrhage, and return to normal oral intake following surgery.

Multiple follow-up visits over 6 weeks

Trial Site Locations

Total: 4 locations

1

Loma Linda University Professional Building - Murrieta

Murrieta, California, United States, 92563

Not Yet Recruiting

2

Loma Linda University ENT/Head & Neck Surgery

Riverside, California, United States, 92506

Actively Recruiting

3

Pediatric Ear, Nose, and Throat Surgery and Audiology

San Bernardino, California, United States, 92408

Not Yet Recruiting

4

SAC Health - ENT Clinic

San Bernardino, California, United States, 92410

Not Yet Recruiting

Loading map...

Research Team

S

Shannon Calaguas, MD

E

Ethan Frank, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Master Protocol for Phase 3 Randomized, Double-Blind, Plac...

Sleep Apnea, Obstructive

Actively Recruiting

129 locations

Accuracy of the Sensory Test Performed Using the Laryngophar...

Sleep Apnea, Obstructive

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Postoperative characteristics of combined pharyngoplasty and tonsillectomy versus tonsillectomy in children with obstructive sleep apnea syndrome.

Yan Shu, Hong-Bing Yao, Da-Zhi Yang...

https://pubmed.ncbi.nlm.nih.gov/30204981