Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy

• Sponsor: Loma Linda University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05575401
• Collaborator: (none)
• Enrollment: 160
• Locations: 4
• Arms: 2
• Patients Per Site: 40

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep-Disordered Breathing; Sleep Apnea Syndromes in Children; Sleep Apnea, Obstructive; Tonsillitis; Tonsillar Hypertrophy; Tonsil Stone; Tonsil Disease	Procedure: Lateral pharyngoplasty; Procedure: Tonsillectomy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Single (Participant)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Post-operative Outcomes of Tonsillectomy With Lateral Pharyngoplasty Versus Tonsillectomy Alone in Children: a Randomized Controlled Trial
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tonsillectomy +/- adenoidectomy Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.	Procedure: Tonsillectomy; Extracapsular tonsillectomy
Experimental: Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.	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.; Procedure: Tonsillectomy; Extracapsular tonsillectomy

Outcome Measures

Primary Outcome Measures

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

   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.

2. Number of participants with post-tonsillectomy hemorrhage requiring surgical intervention [Change between baseline (immediately post-op) through 6 weeks after surgery]

   Count of subjects who undergo control of post-tonsillectomy hemorrhage in the operating room

3. Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention [Change between baseline (immediately post-op) through 6 weeks after surgery]

   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

Secondary Outcome Measures

1. Post-operative duration (in days) to normal oral intake [Change between baseline (immediately post-op) through 6 weeks after surgery]

   Parent/caregiver's will estimate the participant's daily soft diet oral intake as a percentage of perceived baseline/normal

Other Outcome Measures

1. Number of participants requiring intravenous fluid administration for dehydration [Change between baseline (immediately post-op) through 6 weeks after surgery]

   Presentation to healthcare facility due to lack of/perceived inadequate oral intake or decreased urination requiring intravenous fluid administration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Professional Building - Murrieta	Murrieta	California	United States	92563
2	Loma Linda University ENT/Head & Neck Surgery	Riverside	California	United States	92506
3	Pediatric Ear, Nose, and Throat Surgery and Audiology	San Bernardino	California	United States	92408
4	SAC Health - ENT Clinic	San Bernardino	California	United States	92410

Sponsors and Collaborators

• Loma Linda University

Investigators

• Principal Investigator: Tsungju O-Lee, MD, Loma Linda University Health

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Loma Linda University
• ClinicalTrials.gov Identifier: NCT05575401
• Other Study ID Numbers: 5210282
• First Posted: Oct 12, 2022
• Last Update Posted: Feb 1, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Loma Linda University: Tonsillectomy; Post-tonsillectomy hemorrhage; Post-tonsillectomy complication; Lateral pharyngoplasty
• Additional relevant MeSH terms: Tonsillitis; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertrophy

Study Results

No Results Posted as of Feb 1, 2023