Tonsillitis RecurrentNCT06606262
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
A study testing Tonsillotomy and Tonsillectomy in people with Tonsillitis Recurrent, run by Tejs Ehlers Klug at 2 sites in Denmark.
Trial summary
Background: recurrent acute tonsillitis (RT) is a frequent condition affecting teenagers and adults. Patients suffer from recurring throat symptoms, fever and impaired quality of life (QOL). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Tonsillitis Recurrent
- What is being tested?
- Tonsillotomy and Tonsillectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesDenmark
- Study dates
- 31 Oct 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aalborg University Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus, 8200
About this study
Official title: Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis: A Randomized Controlled Non-inferiority Trial
Background: recurrent acute tonsillitis (RT) is a frequent condition affecting teenagers and adults. Patients suffer from recurring throat symptoms, fever and impaired quality of life (QOL). Tonsillectomy (TE) is the only well-known treatment, but studies indicate that tonsillotomy (TO) is associated with less morbidity (eg. pain and bleeding) and equal efficiency (e.g. reduced number of sore throat episodes and improved QOL). The investigator aim to clarify whether TO is a non-inferior alternative to TE.
Methods: inclusion and randomization of 250 adult RT patients for TE or TO with a 12 month follow up. Comparisons will be made between groups, and outcome measures includes number of sore throat episodes, QOL and postoperative pain.
Discussion: the study has the potential to improve the treatment of a prevalent disease by enhancing knowledge of an alternative procedure (TO) associated with less discomfort and risk than the current standard procedure (TE) and a presumably low risk of insufficiency.
- Conditions
- Tonsillitis Recurrent
- Being tested
- Tonsillotomy, Tonsillectomy
- Keywords
- tonsillectomy, tonsillotomy, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonsillotomyProcedure or surgery
Also called Intracapsular tonsillectomy, TO
Bilateral partial removal of the palatine tonsils to a level between the pharyngeal pillars and the tonsillar capsule. Surgery will be performed under general anesthesia using monopolar electrocautery.
TonsillectomyProcedure or surgery
Also called Extracapsular tonsillectomy, TE
Bilateral extracapsular removal of palatine tonsils. Surgery will be performed under general anesthesia using "cold knife" dissection.
| Study group | Role | What they receive |
|---|---|---|
| Tonsillotomy | Experimental | A potential non-inferior surgical procedure for treating recurrent acute tonsillitis. Receives: Procedure: Tonsillotomy |
| Tonsillectomy | Active comparator | The current standard surgical procedure for treating recurrent acute tonsillitis. Receives: Procedure: Tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sore throat episodes after TE vs. TO.
Measured: 12 months (and 24, 36 and 60 months)
QOL measured as postoperative Tonsillectomy Outcome Inventory 14 (TOI-14) score after TE vs. TO
A disease-specific questionnaire for adults with tonsillitis. It is used pre- and postoperatively to detect changes in quality of life. It consists of 14 questions that covers four subscales: throat dis-comfort (question 1-4) general health (question 5-6), resources (question 7-10), and social psychological restrictions (question 11-14). The questionnaire uses a six-point Likert scale with 0 representing "no problem" and 5 representing "couldn't be worse". The points are summed, divided by the number of questions multiplied by 5, and multiplied by 100, giving scores in the range 0-100, where higher scores reflect poorer quality of life
Measured: 12 months (and 24, 36 and 60 months)
Summarized postoperative pain scores (days 1-10)
Measured on a numeric rating scale from 0 til 10 in which 0 represents "no pain" and 10 represents "excruciating pain"
Measured: Days 1-10
Overall postoperative discomfort (day 21)
Measured on a numeric rating scale from 0 til 10 in which 0 represents "no discomfort" and 10 represents "excruciating discomfort"
Measured: Day 21
Secondary outcomes (5)
Proportion of patients cured (defined as postoperative TOI-14<15) after TE vs. TO
Measured: 12 months (and 24, 36 and 60 months)
Overall patient satisfaction after TE vs. TO
Patients will be asked the following question: "Keeping in mind your full experience and the effects of surgery so far, are you satisfied with having undergone surgery?. Possible answers are 1) "yes", 2) "no" and 3) "I don't know"
Measured: 12 months (and 24, 36 and 60 months)
Postoperative Glasgow Benefit Inventory (GBI) score after TE vs. TO
A generic questionnaire for otorhinolaryngological interventions. It is used post-intervention to detect changes in quality of life. It consists of 18 questions that covers three subscales: a general health sub-scale (question 1-6, 9-10, 14, 16-18), a social support subscale (question 7, 11 and 15) and a physical health subscale (question 8, 12-13). The questionnaire uses a five-point Likert scale with 1 representing "worst change of health status" and 5 representing "best change of health status". The points are summed and divided by the number of questions (resulting in average scores), and by subtracting 3 and multiplying by 50, the final scores range from -100 to +100. 0 indicates no change, higher scores reflect better quality of life
Measured: 12 months (and 24, 36 and 60 months)
Number of sore throat days after TE vs. TO
Measured: 12 months (and 24, 36 and 60 months)
Prevalence of reoperation after TE vs. TO
Measured: 12 months (and 24, 36 and 60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start31 Oct 2024
- Primary completion18 Jun 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsillitis RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tejs Ehlers Klug
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor-investigator, Tejs Ehlers Klug, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606262
- Sponsor's protocol ID
- TETO study protocol
- Status last verified
- Jul 2026
- First submitted
- 26 Aug 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis: A Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06606262
- Acronym / sponsor ID
- TETO study protocol
- Conditions
- Tonsillitis Recurrent
- Keywords
- tonsillectomy, tonsillotomy, quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tejs Ehlers KlugUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 18 Jun 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: recurrent acute tonsillitis (RT) is a frequent condition affecting teenagers and adults. Patients suffer from recurring throat symptoms, fever and impaired quality of life (QOL). Tonsillectomy (TE) is the only well-known treatment, but studies indicate that tonsillotomy (TO) is associated with less morbidity (eg. pain and bleeding) and equal efficiency (e.g. reduced number of sore throat episodes and improved QOL). The investigator aim to clarify whether TO is a non-inferior alternative to TE.
Methods: inclusion and randomization of 250 adult RT patients for TE or TO with a 12 month follow up. Comparisons will be made between groups, and outcome measures includes number of sore throat episodes, QOL and postoperative pain.
Discussion: the study has the potential to improve the treatment of a prevalent disease by enhancing knowledge of an alternative procedure (TO) associated with less discomfort and risk than the current standard procedure (TE) and a presumably low risk of insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tonsillotomy | Experimental | Procedure: TonsillotomyA potential non-inferior surgical procedure for treating recurrent acute tonsillitis. |
| Tonsillectomy | Active comparator | Procedure: TonsillectomyThe current standard surgical procedure for treating recurrent acute tonsillitis. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TonsillotomyAlso: Intracapsular tonsillectomy, TOBilateral partial removal of the palatine tonsils to a level between the pharyngeal pillars and the tonsillar capsule. Surgery will be performed under general anesthesia using monopolar electrocautery. | Procedure or surgery | Tonsillotomy |
| TonsillectomyAlso: Extracapsular tonsillectomy, TEBilateral extracapsular removal of palatine tonsils. Surgery will be performed under general anesthesia using "cold knife" dissection. | Procedure or surgery | Tonsillectomy |
Primary outcome
Number of sore throat episodes after TE vs. TO.
Time frame: 12 months (and 24, 36 and 60 months)
QOL measured as postoperative Tonsillectomy Outcome Inventory 14 (TOI-14) score after TE vs. TO
Time frame: 12 months (and 24, 36 and 60 months)
A disease-specific questionnaire for adults with tonsillitis. It is used pre- and postoperatively to detect changes in quality of life. It consists of 14 questions that covers four subscales: throat dis-comfort (question 1-4) general health (question 5-6), resources (question 7-10), and social psychological restrictions (question 11-14). The questionnaire uses a six-point Likert scale with 0 representing "no problem" and 5 representing "couldn't be worse". The points are summed, divided by the number of questions multiplied by 5, and multiplied by 100, giving scores in the range 0-100, where higher scores reflect poorer quality of life
Summarized postoperative pain scores (days 1-10)
Time frame: Days 1-10
Measured on a numeric rating scale from 0 til 10 in which 0 represents "no pain" and 10 represents "excruciating pain"
Overall postoperative discomfort (day 21)
Time frame: Day 21
Measured on a numeric rating scale from 0 til 10 in which 0 represents "no discomfort" and 10 represents "excruciating discomfort"
5 secondary outcomes
Proportion of patients cured (defined as postoperative TOI-14<15) after TE vs. TO
Time frame: 12 months (and 24, 36 and 60 months)
Overall patient satisfaction after TE vs. TO
Time frame: 12 months (and 24, 36 and 60 months)
Postoperative Glasgow Benefit Inventory (GBI) score after TE vs. TO
Time frame: 12 months (and 24, 36 and 60 months)
Number of sore throat days after TE vs. TO
Time frame: 12 months (and 24, 36 and 60 months)
Prevalence of reoperation after TE vs. TO
Time frame: 12 months (and 24, 36 and 60 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonsillotomy and Tonsillectomy in people with Tonsillitis Recurrent, run by Tejs Ehlers Klug at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sore throat episodes after TE vs. TO. (time frame: 12 months (and 24, 36 and 60 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.