Lateral Pharyngoplasty + Tonsillectomy for Tonsillitis

Recruiting at 3 trial locations

Overseen By Shannon Calaguas, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Congenital syndromes, Developmental delay, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-operative period

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining two surgical techniques, lateral pharyngoplasty and tonsillectomy, results in better recovery for children with tonsillitis compared to a tonsillectomy alone. Researchers aim to determine if this combination reduces pain, improves eating and drinking after surgery, and lowers the risk of bleeding. They will compare children who undergo only a tonsillectomy with those who receive both procedures. Children aged 3 to 17 who require a tonsillectomy and do not have conditions like developmental delays or cancer may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially enhance surgical outcomes for future patients.

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 prior data suggests that lateral pharyngoplasty with tonsillectomy is safe for children?

Research has shown that combining lateral pharyngoplasty with tonsillectomy is generally safe for patients. This combined surgery often treats obstructive sleep apnea, and studies have found it significantly improves breathing during sleep. Although these studies focus on different conditions, they suggest the procedure is safe.

For lateral pharyngoplasty surgery, serious side effects are not commonly reported. Patients usually experience typical post-surgery symptoms like pain and swelling, which are common in many surgeries. Research has not consistently found unusual or unexpected problems.

In summary, evidence suggests that lateral pharyngoplasty, when combined with tonsillectomy, is a safe option with common and manageable side effects. However, as with any surgery, individual experiences can vary, so discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of lateral pharyngoplasty with tonsillectomy for treating tonsillitis because it offers a novel approach compared to traditional tonsillectomy alone. While standard treatments typically focus on removing the tonsils and sometimes the adenoids, lateral pharyngoplasty adds a technique that reshapes the throat to potentially improve airway function and reduce symptoms. This combined method could provide enhanced relief and better long-term outcomes for patients with chronic tonsillitis, which is why it's generating interest in the medical community.

What evidence suggests that this trial's treatments could be effective for tonsillitis?

This trial will compare two surgical approaches for treating tonsillitis. One group of participants will undergo a tonsillectomy, with or without adenoidectomy. Another group will receive a tonsillectomy, with or without adenoidectomy, combined with lateral pharyngoplasty. Studies have shown that lateral pharyngoplasty, when performed with tonsil removal, may prevent throat collapse, a common issue in conditions like obstructive sleep apnea. This combined surgery might keep the throat open more effectively than tonsil removal alone. Research also suggests that undergoing both surgeries together could reduce postoperative pain and help children eat and drink more easily during recovery. While the main focus has been on throat issues, these findings indicate that the combined surgery could be more beneficial overall. Although specific data for tonsillitis is not yet available, the surgical approach suggests potential advantages. ^{1 2 6 7 8}

Who Is on the Research Team?

Tsungju O-Lee, MD

Principal Investigator

Loma Linda University Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lateral pharyngoplasty
• Tonsillectomy

Trial Overview 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.

How Is the Trial Designed?

Group I: Tonsillectomy +/- adenoidectomy with lateral pharyngoplasty Experimental Treatment 2 Interventions

Participants will undergo extracapsular tonsillectomy +/- adenoidectomy and lateral pharyngoplasty.

Group II: Tonsillectomy +/- adenoidectomy Active Control 1 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

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

A systematic review of 9 studies involving 312 adult patients with obstructive sleep apnea found that both lateral pharyngoplasty (LP) and uvulopalatopharyngoplasty (UPPP) significantly improved sleep apnea symptoms, including apnea-hypopnea index and daytime sleepiness.

While lateral pharyngoplasty showed slightly better post-operative outcomes compared to UPPP, the differences were not statistically significant, indicating that both procedures are effective options for treating obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lateral pharyngoplasty vs. traditional uvulopalatopharyngoplasty for patients with OSA: systematic review and meta-analysis. Maniaci, A., Di Luca, M., Lechien, JR., et al.[2022]

In a study of 481 patients who underwent adenotonsillectomy, the overall prevalence of postoperative complications was relatively low, with primary bleeding at 4.1% and secondary bleeding at 3.9%.

The most common complications were dysphagia (29.0%) and wound pain (48.1%), indicating that while serious complications are infrequent, discomfort and swallowing difficulties are more prevalent after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of tonsillectomy and adenoidectomy complication at Phramongkutklao Hospital. Muninnobpamasa, T., Khamproh, K., Moungthong, G.[2012]

A study of 267 tonsillectomy patients revealed a low complication rate, with only 2.6% experiencing trauma and 1.1% facing difficult intubation, indicating that the procedure is generally safe.

The risk of primary and respiratory complications increased with longer surgery times, suggesting that minimizing surgery duration could enhance safety, especially for patients with obstructive sleep apnea (OSA), who should avoid outpatient tonsillectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting safe tonsillectomy for ambulatory surgery. Ahmad, R., Abdullah, K., Amin, Z., et al.[2010]

In a study involving 484 children aged 0 to 8 years undergoing tonsillectomy, premedication with inhaled albuterol significantly reduced the occurrence of perioperative respiratory adverse events, with only 27.8% of the albuterol group experiencing such events compared to 47.9% in the placebo group.

Specific respiratory issues like laryngospasm, coughing, and oxygen desaturation were notably lower in the albuterol group, indicating that albuterol is an effective premedication option to enhance safety during tonsillectomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Albuterol Premedication vs Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: The REACT Randomized Clinical Trial. von Ungern-Sternberg, BS., Sommerfield, D., Slevin, L., et al.[2020]

A 7-year-old boy developed a rare complication after adenotonsillectomy, specifically a synechia between the posterior plicae and recurrence of adenoid hypertrophy, which required surgical intervention one year post-operation.

The complication was likely due to a traumatic injury during the initial tonsillectomy, highlighting the importance of careful surgical technique to minimize risks, although such complications are uncommon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior plica synechia: rare complication of adenotonsillectomy. Çiçek, MT., Croo, A., Kizilay, A.[2012]

In a study of 603 children with obstructive sleep apnea, combining tonsillectomy with pharyngoplasty significantly reduced blood loss and shortened the healing process compared to tonsillectomy alone.

Postoperative complications, including velopharyngeal function, were not adversely affected by the addition of pharyngoplasty, suggesting it is a safe and effective option for treating obstructive sleep apnea in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative characteristics of combined pharyngoplasty and tonsillectomy versus tonsillectomy in children with obstructive sleep apnea syndrome. Shu, Y., Yao, HB., Yang, DZ., et al.[2019]

Lateral pharyngotomy provides excellent access for removing laryngeal and hypopharyngeal tumors while minimizing damage to voice, swallowing, and airway function.

The technique is adaptable for various tumors and can include radical neck dissection, with satisfactory cosmetic outcomes, allowing for alternative incision styles if needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences in lateral pharyngotomy. Ferguson, GB.[2004]

In a study of 85 children aged 2 to 14 years, tonsillectomy significantly improved swallowing-related quality of life (SWAL-QOL) scores and the ability to tolerate a regular diet in children suffering from dysphagia due to tonsillar hypertrophy, with improvements noted one month post-surgery.

Both the dysphagia cohort and a control group showed increased weight percentiles for age after tonsillectomy, indicating that the procedure not only alleviates swallowing difficulties but also contributes to better overall health outcomes in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of tonsillectomy for pediatric patients with Dysphagia and tonsillar hypertrophy. Clayburgh, D., Milczuk, H., Gorsek, S., et al.[2015]

In a review of seven studies involving children with recurrent throat infections, tonsillectomy led to a significant short-term reduction in the number of throat infections, doctor visits, and school absences compared to watchful waiting.

However, the benefits of tonsillectomy did not persist beyond the first year, and there were no significant differences in long-term outcomes or quality of life between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tonsillectomy Versus Watchful Waiting for Recurrent Throat Infection: A Systematic Review. Morad, A., Sathe, NA., Francis, DO., et al.[2018]

In a study of 20 patients who underwent lateral pharyngoplasty, all patients experienced complete normalization of swallowing function, with an average recovery time of 21.6 days, and a maximum of 33 days.

The preservation of the stylopharyngeus muscle during the surgery was crucial, as it is important for swallowing, allowing patients to return to normal feeding habits in about 10.9 days post-operation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of swallowing in lateral pharyngoplasty with stylopharyngeal muscle preservation. Mesti, JJ., Cahali, MB.[2022]

A total of 652 adverse events related to electrosurgical devices used in tonsillectomy were reported, with 30% resulting in known bodily injury, highlighting significant safety concerns associated with these devices.

The most common complications included device failures and burn injuries, particularly from coblation devices, which accounted for 42% of burn events, indicating a need for careful monitoring and management during tonsillectomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rare electrosurgical complications in tonsillectomy: Analysis of national adverse event reporting. Yamasaki, A., Bhattacharyya, N.[2020]

Outpatient diode laser tonsillotomy in 183 children with noninflammatory tonsillar hyperplasia resulted in very low postoperative pain and no secondary bleeding, indicating a safe and effective surgical option.

The procedure showed high effectiveness in alleviating symptoms like snoring and obstructed breathing, with parental satisfaction rated very high, especially in children who received postoperative antibiotics, which minimized pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Outpatient diode laser tonsillotomy in children with tonsillar hyperplasia. Clinical results]. Sedlmaier, B., Bohlmann, P., Jakob, O., et al.[2021]

In a review of six trials involving 528 participants, lidocaine spray was found to be more effective than saline spray in reducing pain severity after tonsillectomy, but only for the first three days post-surgery.

The overall quality of the studies was low, with high risk of bias and inadequate data, indicating a need for better-designed future trials to assess the effectiveness of topical agents in tonsillectomy recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy. Fedorowicz, Z., Al-Muharraqi, MA., Nasser, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6537807/

Expansion Sphincter Pharyngoplasty for OSA Expansion sphincter pharyngoplasty may reduce lateral pharyngeal collapse in patients with moderate or severe obstructive sleep apnea and palatal ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06119841

Tonsillectomy and Expansion Sphincter Pharyngoplasty ... To compare the efficacy of tonsillectomy and expansion sphincter pharyngoplasty (ESP) in the surgical treatment of obstructive sleep apnea (OSA). Drug and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6340325/

Expansion Sphincter Pharyngoplasty for Sleep Apnea Treatment Effectiveness of the expansion sphincter pharyngoplasty in patients were assessed based on the PSG results recorded in the postoperative third month. Post ...

4. nature.com nature.com/articles/s41598-020-58920-9

Efficacy of relocation pharyngoplasty for retropalatal narrowing Indications for and Outcomes of Expansion Sphincter Pharyngoplasty to Treat Lateral Pharyngeal Collapse in Patients with Obstructive Sleep Apnea ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/08869634.2024.2381811

Tonsillectomy vs. Expansion Sphincter Pharyngoplasty for OSA To compare the efficacy of tonsillectomy and expansion sphincter pharyngoplasty (ESP) in the surgical treatment of obstructive sleep apnea (OSA).

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0194599807002872

A new technique for the treatment of obstructive sleep apnea In this study, we assessed the efficacy of a new method (expansion sphincter pharyngoplasty [ESP]) to treat obstructive sleep apnea.

7. mdpi.com mdpi.com/2624-5175/7/3/38

Uvulopalatopharyngoplasty Versus Expansion Sphincter ... Expansion sphincter pharyngoplasty (ESP) isolates and rotates the palatopharyngeal muscle while leaving the superior pharyngeal constrictor muscle intact, ...

8. researchgate.net researchgate.net/publication/331602878_Indications_for_and_Outcomes_of_Expansion_Sphincter_Pharyngoplasty_to_Treat_Lateral_Pharyngeal_Collapse_in_Patients_With_Obstructive_Sleep_Apnea

Indications for and Outcomes of Expansion Sphincter ... Expansion sphincter pharyngoplasty (ESP) has been shown to more effectively improve nocturnal respiratory parameters and daytime sleepiness relative to UPPP [18 ...