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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline (immediately post-op) through 6 weeks after surgery
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I am between 3-17 years old and will have my tonsils removed at Loma Linda University Health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline (immediately post-op) through 6 weeks after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline (immediately post-op) through 6 weeks after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Level of post-operative pain
Number of participants with post-tonsillectomy hemorrhage not requiring surgical intervention
Hemorrhage
Secondary outcome measures
Post-operative duration (in days) to normal oral intake
Other outcome measures
Dehydration

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
304 Previous Clinical Trials
259,328 Total Patients Enrolled
Tsungju O-Lee, MDPrincipal InvestigatorLoma Linda University Health

Media Library

Tonsillectomy Clinical Trial Eligibility Overview. Trial Name: NCT05575401 — N/A
Tonsillar Enlargement Research Study Groups: Tonsillectomy +/- adenoidectomy, Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty
Tonsillar Enlargement Clinical Trial 2023: Tonsillectomy Highlights & Side Effects. Trial Name: NCT05575401 — N/A
Tonsillectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05575401 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollment options for this research project?

"According to the listings on clinicaltrials.gov, this investigation is no longer recruiting candidates; though it was initially posted in December of 2022 and last edited October 10th 2022. Fortunately, there are 377 other studies actively accepting participants at present."

Answered by AI

Is the enrollment process open to individuals aged 55 or older for this clinical trial?

"As outlined in the trial's criteria, children of a minimum age of 3 and maximum age of 17 can participate."

Answered by AI

Is there an opportunity for me to volunteer in this medical experiment?

"To be considered for this sleep apnea trial, participants must have obstructive sleep apnoea and fall within the 3-17 age range. Approximately 160 individuals are being accepted into this research study."

Answered by AI
~15 spots leftby May 2024