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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05575401
Other study ID # 5210282
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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