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Lateral Pharyngoplasty + Tonsillectomy for Tonsillitis
N/A
Recruiting
Led By Tsungju O-Lee, MD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at Loma Linda University Health
Be younger than 18 years old
Must not have
Subjects undergoing intracapsular tonsillectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline (immediately post-op) through 6 weeks after surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find out if adding lateral pharyngoplasty to tonsillectomy helps reduce pain, improve eating/drinking, and lower the risk of bleeding after surgery.
Who is the study for?
This trial is for children aged 3-17 who are having their tonsils removed, possibly along with adenoids, at Loma Linda University Health. It's not for kids with congenital syndromes or developmental delays, those getting a specific type of tonsil removal called intracapsular tonsillectomy, kids with cancer, or those dependent on a feeding tube.
What is being tested?
The study is testing if adding lateral pharyngoplasty to the usual tonsil removal surgery helps reduce pain after surgery, improves eating and drinking post-operation, and lowers bleeding risks in children. Some will have both procedures while others just the tonsillectomy to compare outcomes.
What are the potential side effects?
Potential side effects may include discomfort from surgical areas, difficulty swallowing due to swelling or soreness post-surgery, and possible bleeding which is being specifically studied as an outcome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 3-17 years old and will have my tonsils removed at Loma Linda University Health.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am having my tonsils removed without affecting surrounding tissues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between baseline (immediately post-op) through 6 weeks after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline (immediately post-op) through 6 weeks after surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Level of post-operative pain
Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention
Hemorrhage
Secondary study objectives
Post-operative duration (in days) to normal oral intake
Other study objectives
Dehydration
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Tonsillectomy +/- adenoidectomy with lateral pharyngoplastyExperimental Treatment2 Interventions
Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.
Group II: Tonsillectomy +/- adenoidectomyActive Control1 Intervention
Participants will undergo extracapsular tonsillectomy +/- adenoidectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tonsillectomy
2022
Completed Phase 4
~420
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
316 Previous Clinical Trials
266,540 Total Patients Enrolled
Tsungju O-Lee, MDPrincipal InvestigatorLoma Linda University Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 3-17 years old and will have my tonsils removed at Loma Linda University Health.I am having my tonsils removed without affecting surrounding tissues.You have a condition that you were born with or have a delay in your development.You rely on a gastrostomy tube for eating.I have cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Tonsillectomy +/- adenoidectomy
- Group 2: Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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