Lateral Pharyngoplasty + Tonsillectomy for Tonsillitis
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byTsungju O-Lee, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Loma Linda University
Disqualifiers: Congenital syndromes, Developmental delay, Cancer, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It's best to consult with the trial coordinators or your doctor for guidance.
What data supports the effectiveness of the treatment Lateral Pharyngoplasty + Tonsillectomy for Tonsillitis?
Research shows that combining pharyngoplasty with tonsillectomy can have postoperative advantages for children with obstructive sleep apnea, suggesting potential benefits for similar conditions. Additionally, tonsillectomy is effective for treating issues like dysphagia (difficulty swallowing) related to enlarged tonsils.
12345Is tonsillectomy generally safe for humans?
Tonsillectomy is a common procedure and is generally considered safe, but it can have complications like pain, bleeding, and respiratory issues, especially in children. Advances in surgical techniques and anesthesia have reduced these risks.
678910How does the treatment of Lateral Pharyngoplasty + Tonsillectomy for Tonsillitis differ from other treatments?
Lateral Pharyngoplasty combined with Tonsillectomy is unique because it involves repositioning muscles in the throat to improve airflow, which is particularly beneficial for conditions like obstructive sleep apnea. This approach is different from traditional tonsillectomy alone, which primarily focuses on removing the tonsils without addressing muscle positioning.
24111213Eligibility Criteria
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.Inclusion Criteria
I am between 3-17 years old and will have my tonsils removed at Loma Linda University Health.
Exclusion Criteria
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.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo tonsillectomy +/- adenoidectomy with or without lateral pharyngoplasty
Immediate post-operative period
1 visit (in-person for surgery)
Follow-up
Participants are monitored for post-operative outcomes such as pain, oral intake, and hemorrhage
6 weeks
Regular follow-up visits as needed
Participant Groups
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.
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.
Tonsillectomy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Tonsillectomy for:
- Obstructive Sleep Apnea (OSA)
- Recurrent Tonsillitis
🇪🇺 Approved in European Union as Tonsillectomy for:
- Obstructive Sleep Apnea (OSA)
- Recurrent Tonsillitis
- Tonsillar Hypertrophy
🇨🇦 Approved in Canada as Tonsillectomy for:
- Obstructive Sleep Apnea (OSA)
- Recurrent Tonsillitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
SAC Health - ENT ClinicSan Bernardino, CA
Loma Linda University Professional Building - MurrietaMurrieta, CA
Loma Linda University ENT/Head & Neck SurgeryRiverside, CA
Pediatric Ear, Nose, and Throat Surgery and AudiologySan Bernardino, CA
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Who Is Running the Clinical Trial?
Loma Linda UniversityLead Sponsor
References
Efficacy of tonsillectomy for pediatric patients with Dysphagia and tonsillar hypertrophy. [2015]To determine the effectiveness of tonsillectomy for the treatment of dysphagia related to tonsillar hypertrophy.
Lateral pharyngoplasty vs. traditional uvulopalatopharyngoplasty for patients with OSA: systematic review and meta-analysis. [2022]To compare the efficacy and success rates of lateral pharyngoplasty techniques (LP) vs. uvulopalatopharyngoplasty (UPPP) among adult patients surgically treated for obstructive sleep apnea.
Tonsillectomy Versus Watchful Waiting for Recurrent Throat Infection: A Systematic Review. [2018]The effectiveness of tonsillectomy or adenotonsillectomy ("tonsillectomy") for recurrent throat infection compared with watchful waiting is uncertain.
Postoperative characteristics of combined pharyngoplasty and tonsillectomy versus tonsillectomy in children with obstructive sleep apnea syndrome. [2019]The study aims to identify the postoperative advantages of tonsillectomy in conjunction with pharyngoplasty and tonsillectomy alone in children with obstructive sleep apneas.
[Outpatient diode laser tonsillotomy in children with tonsillar hyperplasia. Clinical results]. [2021]The aim of this retrospective study was to present the postoperative development, therapy effectiveness, and parental satisfaction after an outpatient diode laser tonsillotomy in children with noninflammatory tonsillar hyperplasia.
Predicting safe tonsillectomy for ambulatory surgery. [2010]To assess the safety of tonsillectomy procedure in local setting.
Prevalence of tonsillectomy and adenoidectomy complication at Phramongkutklao Hospital. [2012]Tonsillectomy and adenoidectomy, one of the major procedures among otolaryngologist, may have risk in post operative complications which can be either non severe complications (dysphagia, wound pain, dehydration) or serious complications (Bleeding, partial airway obstruction). Meticulous attention to surgical techniques and technical advance in anesthesiology have significantly reduced the number of complications. In Thailand, there are few reports about the adenotonsillectomy complications so the objectives of the present study were to determine the prevalence and related risk factors in patients visiting the department of Otolaryngology, Phramongkutklao Hospital.
Effect of Albuterol Premedication vs Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: The REACT Randomized Clinical Trial. [2020]Tonsillectomy is a common pediatric procedure for the treatment of sleep-disordered breathing and chronic tonsillitis. Up to half of children having this procedure experience a perioperative respiratory adverse event.
Rare electrosurgical complications in tonsillectomy: Analysis of national adverse event reporting. [2020]To identify U.S. Food and Drug Administration (FDA)-reported adverse events related to electrosurgical devices during tonsillectomy and characterize the most common devices and patient/provider sequelae.
Oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy. [2020]This is an update of a Cochrane Review first published in The Cochrane Library in Issue 1, 2010.Tonsillectomy is the surgical removal of lymphoid tissue, the palatine tonsil, which is located at the back of the throat. It is still commonly performed for patients who have recurrent bouts of acute tonsillitis. Although tonsillectomy is considered a fairly minor procedure, pain and bleeding are two of the most common complications; either may delay recovery and can on occasion lead to hospital readmission. Postoperative tonsillectomy medication should provide an adequate reduction in morbidity while minimising side effects, therefore topical agents would seem to be an ideal, safe option. A number of mouthwashes and topical sprays are available which offer pain relief or can help to reduce bleeding in the immediate postoperative period.
Experiences in lateral pharyngotomy. [2004]Lateral pharyngotomy offers good exposure for the removal of many laryngeal and hypopharyngeal tumors. The simplified operation I present avoids damage to voice, deglutition or airway. This approach can be expanded to reach almost any tumor of the pharynx and radical neck dissection can be incorporated. The cosmetic result has been satisfactory, but if individual consideration prompts it, a more horizontal skin-fold incision can easily be substituted.
Posterior plica synechia: rare complication of adenotonsillectomy. [2012]Tonsillectomy is one of the most common operations performed by otolaryngologists. Fever, otalgia, dehydration, sore throat, and hemorrhage are common complications. In this clinical report, a 7-year-old boy was presented with a synechia between the posterior plicae together with recurrence of adenoid hypertrophy after adenotonsillectomy 1 year previously. The synechia and adenoid were resected, and the patient was discharged from the hospital after 2 days. The complication in this case was most likely caused by traumatic injury of the posterior plicae during the previous tonsillectomy. This complication is, however, very rare.
Evolution of swallowing in lateral pharyngoplasty with stylopharyngeal muscle preservation. [2022]Lateral pharyngoplasty manages obstructive sleep apnea through the myotomy and repositioning of the muscles of the lateral pharyngeal wall. Dysphagia after any pharyngeal surgery is influenced by pain, discomfort from the sutures, the healing process and by the adaptation to the changes in pharyngeal structures. Experience with lateral pharyngoplasty has shown that the superior pharyngeal constrictor muscle plays a minor role in swallowing. One of them, the stylopharyngeus muscle, seems to play an important role during swallowing.