Clinical trial NCT05575401: Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
Official title: Post-operative Outcomes of Tonsillectomy With Lateral Pharyngoplasty Versus Tonsillectomy Alone in Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Level of post-operative pain
timeFrame: Change between baseline (immediately post-op) through 6 weeks after surgery
measure: Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention
timeFrame: Change between baseline (immediately post-op) through 6 weeks after surgery
measure: Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention
timeFrame: Change between baseline (immediately post-op) through 6 weeks after surgery
Secondary outcomes:
measure: Post-operative duration (in days) to normal oral intake
timeFrame: Change between baseline (immediately post-op) through 6 weeks after surgery
Other outcomes:
measure: Number of participants requiring intravenous fluid administration for dehydration
timeFrame: Change between baseline (immediately post-op) through 6 weeks after surgery
Locations:
city: Murrieta
country: United States
facility: Loma Linda University Professional Building - Murrieta
state: California
city: Riverside
country: United States
facility: Loma Linda University ENT/Head & Neck Surgery
state: California
city: San Bernardino
country: United States
facility: Pediatric Ear, Nose, and Throat Surgery and Audiology
state: California
city: San Bernardino
country: United States
facility: SAC Health - ENT Clinic
state: California
Study officials:
affiliation: Loma Linda University Health
name: Tsungju O-Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Ramjettan S, Singh B. Are sutured faucial pillars really an advantage in tonsillectomy? S Afr J Surg. 1996 Nov;34(4):189-91.
citation: 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.
citation: 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.