Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

NCT ID: NCT05575401

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2026-01-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tonsillectomy +/- adenoidectomy

Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.

Group Type: ACTIVE_COMPARATOR

Tonsillectomy

Intervention Type: PROCEDURE

Extracapsular tonsillectomy

Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty

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

Group Type: EXPERIMENTAL

Lateral pharyngoplasty

Intervention Type: 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

Intervention Type: PROCEDURE

Extracapsular tonsillectomy

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.

Intervention Type: PROCEDURE

Tonsillectomy

Extracapsular tonsillectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsungju O-Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Health

Locations

Loma Linda University Professional Building - Murrieta

Murrieta, California, United States

Site Status: NOT_YET_RECRUITING

Loma Linda University ENT/Head & Neck Surgery

Riverside, California, United States

Site Status: RECRUITING

Pediatric Ear, Nose, and Throat Surgery and Audiology

San Bernardino, California, United States

Site Status: NOT_YET_RECRUITING

SAC Health - ENT Clinic

San Bernardino, California, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Shannon Calaguas, MD

Role: CONTACT

scalaguas@llu.edu

(909) 558-8558

Ethan Frank, MD

Role: CONTACT

efrank@llu.edu

(909) 558-8558

Facility Contacts

Tsungju O-Lee, MD

Role: primary

tolee@llu.edu

951-290-4000

Tsungju O-Lee, MD

Role: primary

tolee@llu.edu

909-558-2824

Vikrum Thimmappa, MD

Role: backup

vathimmappa@llu.edu

(909) 558-2824

Tsungju O-Lee, MD

Role: primary

tolee@llu.edu

909-558-2824

Vikrum Thimmappa, MD

Role: backup

vathimmappa@llu.edu

(909) 558-2824

Vikrum Thimmappa, MD

Role: primary

vathimmappa@llu.edu

909-382-7100

References

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.

Reference Type: BACKGROUND

PMID: 16414127 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32057680 (View on PubMed)

Ramjettan S, Singh B. Are sutured faucial pillars really an advantage in tonsillectomy? S Afr J Surg. 1996 Nov;34(4):189-91.

Reference Type: BACKGROUND

PMID: 9015944 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30204981 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30611028 (View on PubMed)

Other Identifiers

5210282

Identifier Type: -

Identifier Source: org_study_id