Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575401
• Other study ID #: 5210282
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2023
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: Loma Linda University
• Contact: Shannon Calaguas, MD
• Phone: (909) 558-8558
• Email: scalaguas[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Tonsillectomy
Extracapsular tonsillectomy

Locations

Country	Name	City	State
United States	Loma Linda University Professional Building - Murrieta	Murrieta	California
United States	Loma Linda University ENT/Head & Neck Surgery	Riverside	California
United States	Pediatric Ear, Nose, and Throat Surgery and Audiology	San Bernardino	California
United States	SAC Health - ENT Clinic	San Bernardino	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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	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