Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

NCT05575401 | Recruiting

• 1 other identifier: 5210282
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

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; Tonsil Stone; Tonsil Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

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

Other Outcomes (1)

• Number of participants requiring intravenous fluid administration for dehydration

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

Study Arms (2)

Tonsillectomy +/- adenoidectomy

ACTIVE COMPARATOR

Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.

Procedure: Tonsillectomy

Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty

EXPERIMENTAL

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

Procedure: Lateral pharyngoplasty; Procedure: Tonsillectomy

Interventions

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 +/- adenoidectomy with lateral pharyngoplasty

Tonsillectomy PROCEDURE

Extracapsular tonsillectomy

Tonsillectomy +/- adenoidectomy; Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health

You may not qualify if:

• Subjects with congenital syndromes and/or developmental delay
• Subjects with cancer
• Subjects with gastrostomy tube use or dependence
• Subjects undergoing intracapsular tonsillectomy

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (4)

Loma Linda University Professional Building - Murrieta

Murrieta, California, 92563, United States

NOT YET RECRUITING

Loma Linda University ENT/Head & Neck Surgery

Riverside, California, 92506, United States

RECRUITING

Pediatric Ear, Nose, and Throat Surgery and Audiology

San Bernardino, California, 92408, United States

NOT YET RECRUITING

SAC Health - ENT Clinic

San Bernardino, California, 92410, United States

NOT YET RECRUITING

Related Publications (5)

• 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.

  PMID: 16414127 BACKGROUND

• 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.

  PMID: 32057680 BACKGROUND

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

  PMID: 9015944 BACKGROUND

• 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.

  PMID: 30204981 BACKGROUND

• 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.

  PMID: 30611028 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Tonsillitis; tonsillolith

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Tsungju O-Lee, MD

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Calaguas, MD

CONTACT

(909) 558-8558; scalaguas@llu.edu

Ethan Frank, MD

CONTACT

(909) 558-8558; efrank@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: At the beginning of the study, each surgeon will receive an 80-item numbered list for which a random generator has been used to assign lateral pharyngoplasty or no lateral pharyngoplasty to each study participant. Each participant recruited for the study will undergo the correlating procedure at the time of surgery. Thus, the surgeon is necessarily not blinded, but the participant and parents would be blinded, and informed consent for the procedure would be for tonsillectomy +/- adenoidectomy, possible lateral pharyngoplasty.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants ages 3-17 years undergoing tonsillectomy for any reason will be randomized to either undergo tonsillectomy +/- adenoidectomy (standard of care practice) or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention). Parents of participants in both arms will be given post-operative worksheets to document pain scores, pain medication administration, estimates of daily per os intake, and any complications.

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: May 17, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)