Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea, Obstructive; Tonsillitis; Sleep-Disordered Breathing; Tonsillar Hypertrophy; Sleep Apnea Syndromes in Children; Tonsil Disease; Tonsil Stone
• Intervention / Treatment: Procedure: Tonsillectomy; Procedure: Lateral pharyngoplasty

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shannon Calaguas, MD; Phone Number: (909) 558-8558; Email: scalaguas@llu.edu
• Study Contact Backup: Name: Ethan Frank, MD; Phone Number: (909) 558-8558; Email: efrank@llu.edu

Study Locations

• United States
  • California
    • Murrieta, California, United States, 92563
      • Not yet recruiting
      • Loma Linda University Professional Building - Murrieta
      • Contact: Tsungju O-Lee, MD; Phone Number: 951-290-4000; Email: tolee@llu.edu
      • Sub-Investigator: Vikrum Thimmappa, MD
      • Principal Investigator: Tsungju O-Lee, MD
    • Riverside, California, United States, 92506
      • Recruiting
      • Loma Linda University ENT/Head & Neck Surgery
      • Sub-Investigator: Vikrum Thimmappa, MD
      • Principal Investigator: Tsungju O-Lee, MD
      • Contact: Tsungju O-Lee, MD; Phone Number: 909-558-2824; Email: tolee@llu.edu
      • Contact: Vikrum Thimmappa, MD; Phone Number: (909) 558-2824; Email: vathimmappa@llu.edu
    • San Bernardino, California, United States, 92408
      • Not yet recruiting
      • Pediatric Ear, Nose, and Throat Surgery and Audiology
      • Sub-Investigator: Vikrum Thimmappa, MD
      • Principal Investigator: Tsungju O-Lee, MD
      • Contact: Tsungju O-Lee, MD; Phone Number: 909-558-2824; Email: tolee@llu.edu
      • Contact: Vikrum Thimmappa, MD; Phone Number: (909) 558-2824; Email: vathimmappa@llu.edu
    • San Bernardino, California, United States, 92410
      • Not yet recruiting
      • SAC Health - ENT Clinic
      • Contact: Vikrum Thimmappa, MD; Phone Number: 909-382-7100; Email: vathimmappa@llu.edu
      • Principal Investigator: Vikrum Thimmappa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tonsillectomy +/- adenoidectomy; Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.	Procedure: Tonsillectomy; Extracapsular tonsillectomy
Experimental: Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty; Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.	Procedure: Tonsillectomy; Extracapsular tonsillectomy; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of post-operative pain	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.	Change between baseline (immediately post-op) through 6 weeks after surgery
Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention	Count of subjects who undergo control of post-tonsillectomy hemorrhage in the operating room	Change between baseline (immediately post-op) through 6 weeks after surgery
Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention	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	Change between baseline (immediately post-op) through 6 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative duration (in days) to normal oral intake	Parent/caregiver's will estimate the participant's daily soft diet oral intake as a percentage of perceived baseline/normal	Change between baseline (immediately post-op) through 6 weeks after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants requiring intravenous fluid administration for dehydration	Presentation to healthcare facility due to lack of/perceived inadequate oral intake or decreased urination requiring intravenous fluid administration	Change between baseline (immediately post-op) through 6 weeks after surgery

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Tsungju O-Lee, MD, Loma Linda University Health

Publications and helpful links

General Publications

• Wulu JA, Chua M, Levi JR. Does suturing tonsil pillars post-tonsillectomy reduce postoperative hemorrhage?: A literature review. Int J Pediatr Otorhinolaryngol. 2019 Feb;117:204-209. doi: 10.1016/j.ijporl.2018.12.003. Epub 2018 Dec 4.
• Genc E, Hanci D, Ergin NT, Dal T. Can mucosal sealing reduce tonsillectomy pain? Int J Pediatr Otorhinolaryngol. 2006 Apr;70(4):725-30. doi: 10.1016/j.ijporl.2005.12.005. Epub 2006 Jan 18.
• Kim JS, Kim BG, Kim DH, Hwang SH. Efficacy of pillar suture for post-tonsillectomy morbidity in children: a meta-analysis. Braz J Otorhinolaryngol. 2021 Sep-Oct;87(5):583-590. doi: 10.1016/j.bjorl.2019.12.007. Epub 2020 Jan 25.
• Ramjettan S, Singh B. Are sutured faucial pillars really an advantage in tonsillectomy? S Afr J Surg. 1996 Nov;34(4):189-91.
• Shu Y, Yao HB, Yang DZ, Wang B. Postoperative characteristics of combined pharyngoplasty and tonsillectomy versus tonsillectomy in children with obstructive sleep apnea syndrome. Arch Argent Pediatr. 2018 Oct 1;116(5):316-321. doi: 10.5546/aap.2018.eng.316. English, Spanish.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Tonsillectomy; Post-tonsillectomy hemorrhage; Post-tonsillectomy complication; Lateral pharyngoplasty
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Nervous System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Otorhinolaryngologic Diseases; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Pharyngeal Diseases; Pharyngitis; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Tonsillitis; tonsillolith; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Tonsillectomy
• Other Study ID Numbers: 5210282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No