Comparing tonsillectomy and tonsillotomy for treating recurrent tonsillitis
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis: A Randomized Controlled Non-inferiority Trial
This study is testing whether a less invasive surgery called tonsillotomy can help adults with frequent sore throats just as well as the traditional tonsillectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Aalborg and 1 other locations) |
| Trial ID | NCT06606262 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of tonsillotomy compared to the traditional tonsillectomy in adults suffering from recurrent acute tonsillitis. It aims to enroll 250 participants who will be randomly assigned to receive either tonsillectomy or tonsillotomy, with a follow-up period of 12 months. The primary outcomes include the frequency of sore throat episodes, quality of life improvements, and postoperative pain levels. The goal is to determine if tonsillotomy can serve as a less invasive alternative to tonsillectomy without compromising treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 15 and older who experience recurrent acute tonsillitis as defined by specific episode criteria.
Not a fit: Patients with a history of tonsil surgery, suspected malignancies, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less painful and lower-risk treatment option for patients with recurrent tonsillitis.
How similar studies have performed: Previous studies have suggested that tonsillotomy may be a viable alternative to tonsillectomy, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (age ≥15 years) with RT, defined as a minimum of five tonsillitis episodes in one year or a minimum of three tonsillitis episodes per year for two years (Danish National Guidelines criteria * The ability to understand Danish orally and in writing. Exclusion Criteria: * Previous TE or TO. * Suspected tonsillar malignancy. * History of malignant tumor in the oral cavity, the pharynx or the larynx. * Previous radiation therapy on head or neck. * Hemorrhagic diathesis or anticoagulant therapy.
Where this trial is running
Aalborg and 1 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Hannah Inez Houborg, MD
- Email: hahoub@clin.au.dk
- Phone: +45 21256818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.