Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

Loma Linda University (LLU)

Status: Enrolling

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

Treatments: Procedure: Lateral pharyngoplasty; Procedure: Tonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05575401

5210282

Details and patient eligibility

About

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.

Full description

This is a randomized controlled trial to elucidate the benefits of performing lateral pharyngoplasty with tonsillectomy and encourage its use as a standard of care procedure. Participants will be randomized to receive either tonsillectomy +/- adenoidectomy or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention), with lateral pharyngoplasty referring to the placement two figure-of-8 sutures with 3-0 vicryl to reapproximate the anterior and posterior tonsillar pillars on each side. The investigators' hypothesis is that participants undergoing lateral pharyngoplasty will experience less pain, lower post-tonsillectomy hemorrhage rate, and a faster return to normal oral intake than participants undergoing tonsillectomy alone.

Enrollment: 160 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Tonsillectomy +/- adenoidectomy

Active Comparator group

Description:

Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.

Treatment:

Procedure: Tonsillectomy

Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty

Experimental group

Description:

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

Treatment:

Procedure: Tonsillectomy

Procedure: Lateral pharyngoplasty