Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

Part of paid clinical trials in Murrieta, California.

Sponsor
Loma Linda University
Study ID
NCT05575401
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
3 Years - 17 Years
Healthy Volunteers
Not accepted

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 — PROCEDURE
    Extracapsular tonsillectomy

Study Details

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.

Key Dates

Start date
May 17, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tonsillectomy +/- adenoidectomy
    Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.
  • Experimental: Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty
    Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.

Primary Outcome Measure

Level of post-operative pain [ Time Frame: Change between baseline (immediately post-op) through 6 weeks after surgery ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Loma Linda University Professional Building - MurrietaMurrietaCalifornia92563
Tsungju O-Lee, MD
[email protected]
951-290-4000
Vikrum Thimmappa, MD (SUB_INVESTIGATOR)
Tsungju O-Lee, MD (PRINCIPAL_INVESTIGATOR)
Loma Linda University ENT/Head & Neck SurgeryRiversideCalifornia92506
Tsungju O-Lee, MD
[email protected]
909-558-2824
Vikrum Thimmappa, MD
[email protected]
(909) 558-2824
Vikrum Thimmappa, MD (SUB_INVESTIGATOR)
Tsungju O-Lee, MD (PRINCIPAL_INVESTIGATOR)
Pediatric Ear, Nose, and Throat Surgery and AudiologySan BernardinoCalifornia92408
Tsungju O-Lee, MD
[email protected]
909-558-2824
Vikrum Thimmappa, MD
[email protected]
(909) 558-2824
Tsungju O-Lee, MD (PRINCIPAL_INVESTIGATOR)
Vikrum Thimmappa, MD (SUB_INVESTIGATOR)
SAC Health - ENT ClinicSan BernardinoCalifornia92410
Vikrum Thimmappa, MD
[email protected]
909-382-7100
Vikrum Thimmappa, MD (PRINCIPAL_INVESTIGATOR)

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Loma Linda University Professional Building - Murrieta· Murrieta, CALoma Linda University ENT/Head & Neck Surgery· Riverside, CAPediatric Ear, Nose, and Throat Surgery and Audiology· San Bernardino, CASAC Health - ENT Clinic· San Bernardino, CA

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