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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{2 4 11 12 13}

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.

Research Team

Tsungju O-Lee, MD

Principal Investigator

Loma Linda University Health

Eligibility 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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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 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]

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 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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of tonsillectomy for pediatric patients with Dysphagia and tonsillar hypertrophy. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

Lateral pharyngoplasty vs. traditional uvulopalatopharyngoplasty for patients with OSA: systematic review and meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Tonsillectomy Versus Watchful Waiting for Recurrent Throat Infection: A Systematic Review. [2018]

4. Argentina pubmed.ncbi.nlm.nih.gov

Postoperative characteristics of combined pharyngoplasty and tonsillectomy versus tonsillectomy in children with obstructive sleep apnea syndrome. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[Outpatient diode laser tonsillotomy in children with tonsillar hyperplasia. Clinical results]. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Predicting safe tonsillectomy for ambulatory surgery. [2010]

7. Thailand pubmed.ncbi.nlm.nih.gov

Prevalence of tonsillectomy and adenoidectomy complication at Phramongkutklao Hospital. [2012]

8. United States 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. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Rare electrosurgical complications in tonsillectomy: Analysis of national adverse event reporting. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Experiences in lateral pharyngotomy. [2004]

12. United States pubmed.ncbi.nlm.nih.gov

Posterior plica synechia: rare complication of adenotonsillectomy. [2012]

13. Brazil pubmed.ncbi.nlm.nih.gov

Evolution of swallowing in lateral pharyngoplasty with stylopharyngeal muscle preservation. [2022]