Recruiting

Lateral Pharyngoplasty

Sponsor:

Loma Linda University

Code:

NCT05575401

Conditions

Sleep-Disordered Breathing

Sleep Apnea Syndromes in Children

Sleep Apnea, Obstructive

Tonsillitis

Tonsillar Hypertrophy

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

Lateral pharyngoplasty

Tonsillectomy

Study Details

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.

Conditions

Sleep-Disordered Breathing

Sleep Apnea Syndromes in Children

Sleep Apnea, Obstructive

Tonsillitis

Tonsillar Hypertrophy

Study ID

NCT05575401

Start date

May 17, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Tonsillectomy +/- adenoidectomy

Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.

experimental: Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty

Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.

Interventions

Lateral 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.

Tonsillectomy

Extracapsular tonsillectomy

Primary outcome measure

  • Level of post-operative pain [ Time Frame: Change between baseline (immediately post-op) through 6 weeks after surgery ]
  • Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention [ Time Frame: Change between baseline (immediately post-op) through 6 weeks after surgery ]
  • Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention [ Time Frame: Change between baseline (immediately post-op) through 6 weeks after surgery ]

Central Contacts and Locations

Central contacts

Shannon Calaguas, MD

(909) 558-8558scalaguas@llu.edu

Ethan Frank, MD

(909) 558-8558efrank@llu.edu

Locations

Loma Linda University ENT/Head & Neck Surgery

Recruiting

Riverside, California, United States, 92506

Contacts

Tsungju O-Lee, MD

909-558-2824tolee@llu.edu

Vikrum Thimmappa, MD

(909) 558-2824vathimmappa@llu.edu

Principal Investigator:

Tsungju O-Lee, MD

More Information

Sponsor

Loma Linda University

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-02-23.