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NCT Number: NCT05575401

Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

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.

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Key information

Conditions

Sleep-Disordered Breathing Apnea Dyssomnias Infections Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Sleep Apnea Syndromes Sleep Apnea Syndromes in Children Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases Tonsil Disease Tonsil Stone Tonsillar Hypertrophy Tonsillitis tonsillolith

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Professional Building - Murrieta, Murrieta, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lateral pharyngoplasty

Procedure

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

Procedure

Extracapsular tonsillectomy

Primary outcomes

  1. Level of post-operative pain

    Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery

    Will use the Wong-Baker FACES pain scale, which shows a series of faces ranging from a happy face at 0 (representing no pain) to a crying face at 10 (representing the worst pain imaginable). Parent/caregiver will document the pain score and pain medication administrations/duration of use.

  2. Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention

    Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery

    Count of subjects who undergo control of post-tonsillectomy hemorrhage in the operating room

  3. Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention

    Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery

    Count of subject/caregiver reports or presentations to a healthcare facility due to a post-tonsillectomy hemorrhage event that does not require control of hemorrhage in the operating room

Secondary outcomes

  1. Post-operative duration (in days) to normal oral intake

    Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery

    Parent/caregiver's will estimate the participant's daily soft diet oral intake as a percentage of perceived baseline/normal

Other outcomes

  1. Number of participants requiring intravenous fluid administration for dehydration

    Time frame: Change between baseline (immediately post-op) through 6 weeks after surgery

    Presentation to healthcare facility due to lack of/perceived inadequate oral intake or decreased urination requiring intravenous fluid administration

Study contacts

Contact information is provided by the study sponsor or research team.

Ethan Frank, MD

CONTACT

[email protected]

(909) 558-8558

Shannon Calaguas, MD

CONTACT

[email protected]

(909) 558-8558

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2022
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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