Tonsil DiseaseNCT03654742
Intracapsular Tonsillectomy in Adults
A study testing tonsillectomy in people with Tonsil Disease and Tonsillitis, run by Turku University Hospital at 1 site in Finland.
Trial summary
Comparing the classical extracapsular tonsillectomy (TE) performed with electrosurgery to intracapsular approaches (SIPT) by coblation or microdebrider. The patient group is adults with recurrent or chronic tonsillitis Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Tonsil Disease, Tonsillitis, Tonsillitis Acute
- What is being tested?
- tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteFinland
- Study dates
- 27 Sep 2019to 30 Dec 2028
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16-65 years
- Planned tonsil surgery with informed consent
- Recurrent or chronic tonsillitis
Who cannot join
- Less than 1 month old, drained quinsy
- Acute "hot phase" tonsillitis
- Previous palatine tonsil surgery
- Suspicion or confirmation of malignancy
- High dose analgesics consumption
- Current CPAP-device usage for treatment of OSAS
Show all 11Show fewer
- Untreated gastro-esophageal reflux disease
- Anticoagulative medication
- Any condition of hemophilia
- Pregnancy, lactation
- Current or positive history of malignant disease (if still active follow-up)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracapsular vs Extracapsular Tonsillectomy. A Comparison of Treatment Methods of Recurrent and Chronic Tonsillitis in Adults: a Prospective Single-blinded Randomised Study
Comparing the classical extracapsular tonsillectomy (TE) performed with electrosurgery to intracapsular approaches (SIPT) by coblation or microdebrider. The patient group is adults with recurrent or chronic tonsillitis
Read the detailed description
Extracapsular tonsillectomy (TE) with monopolar electrosurgery is the most commonly used approach in adult tonsil surgery in Turku University Central Hospital, Finland.
In our study setting we are comparing intracapsular tonsillectomy (subtotal/intracapsular/partial tonsillectomy (SIPT) ) as the intervention group with extracapsular tonsillectomy as the control group.
SIPT is done with either coblation or microdebrider and TE with monopolar electrosurgery.
Indications for surgery are recurrent tonsillitis or chronic tonsillitis. The patient group is adults (16-65 years)
Safety, efficiency and cost-effectiveness are monitored in a prospective, patient-blinded and randomised study setting.
- Conditions
- Tonsil Disease, Tonsillitis, Tonsillitis Acute, Tonsillitis Chronic
- Being tested
- tonsillectomy
- Keywords
- tonsil surgery, tonsillectomy, intracapsular, microdebrider, coblation, extracapsular, electrosurgery, electrocautery, adults
- Medical subject headings
- Tonsillitis, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tonsillectomyProcedure or surgery
Also called tonsil removal, tonsil surgery
removal of tonsil tissue as described in the study arms
| Study group | Role | What they receive |
|---|---|---|
| ECTE/Electrosurgery | Active comparator | Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery Receives: Procedure: tonsillectomy |
| ICTE/Microdebrider | Experimental | Intracapsular tonsillectomy (ICTE) with microdebrider Receives: Procedure: tonsillectomy |
| ICTE/Coblator | Experimental | Intrapsular tonsillectomy (ICTE) with coblator Receives: Procedure: tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative recovery
Pain post-operatively after discharge as self-reported pain intensity over the past day. Each day is scored with the modified Brief Pain Inventory and recovery is achieved when pain score reaches preset values. Recovery speed defined as pain VAS-score 3 or less at rest; or pain VAS-score 5 or less without regular analgesics use. Daily questionnaire used: Brief Pain Inventory.
Measured: 21 days
Secondary outcomes (7)
Analgesics use
Need for analgesics postoperatively during 21 days. Measured as number of naprometin tablets/ day and the number of tramadol-paracetamol combination tablets/day.
Measured: 21 days
Post-operative bleeding
Bleeding post-operatively at the ward or at any point during 21 days. Measured as 1-4 (1= bleeding, stopped spontaneously, no contact with staff; 2: Contact with ER, bleeding stopped without intervention; 3: Bleeding, needed intervention (packing, topical adrenalin, electrosurgical hemostasis; 4: Needed OR-time, blood transfusion, ward days
Measured: 21 days
Life Quality
Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 "TOI-14" preoperatively and 6 months after operation;
Measured: 6 months
Residual tonsil tissue
Residual tonsil measured right after surgery is completed and at 6 months follow-up.
Measured: 6 months
Revision surgery
The need of revision surgery after tonsillectomy, recorded with questionnaire: Nordic Tonsil Surgery Register
Measured: 5 years
Throat problems
Throat problems as described by the Nordic Tonsil Surgery Register at different time points postoperatively
Measured: 5 years
Life quality
Quality of life as defined by the questionnaires: Glasgow Benefit Inventory "GBI" at 6 months after operation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start27 Sep 2019
- Primary completion5 Jan 2023
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tonsil DiseaseStudies 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
- Model description
- prospective, single-blinded, randomised, controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jaakko Piitulainen, Turku University Hospital
- Investigators
- Jussi Jero, Professor, Study director, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654742
- Sponsor's protocol ID
- T211/2018
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2018
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data relevant to the study are included in the article or uploaded as supplementary information.
Publications
Piitulainen JM, Uusitalo T, Sjoblom HM, Ivaska LE, Jegoroff H, Kauko T, Kokki H, Kyto E, Mansikka I, Ylikoski J, Jero J. Intracapsular tonsillectomy in the treatment of recurrent and chronic tonsillitis in adults: a protocol of a prospective, single-blinded, randomised study with a 5-year follow-up (the FINITE trial). BMJ Open. 2022 Sep 14;12(9):e062722. doi: 10.1136/bmjopen-2022-062722.
PubMed 36104143Uusitalo T, Sjoblom H, Ivaska LE, Kauko T, Kokki H, Mansikka I, Kyto E, Piitulainen J. Intracapsular vs Extracapsular Tonsillectomy Recovery Time: The FINITE Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Jun 1;152(6):552-559. doi: 10.1001/jamaoto.2026.0284.
PubMed 41954901
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracapsular vs Extracapsular Tonsillectomy. A Comparison of Treatment Methods of Recurrent and Chronic Tonsillitis in Adults: a Prospective Single-blinded Randomised Study
- ClinicalTrials.gov ID
- NCT03654742
- Acronym / sponsor ID
- T211/2018
- Conditions
- Tonsil Disease, Tonsillitis, Tonsillitis Acute, Tonsillitis Chronic
- Keywords
- tonsil surgery, tonsillectomy, intracapsular, microdebrider, coblation, extracapsular, electrosurgery, electrocautery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 31 Aug 2018 (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.
Comparing the classical extracapsular tonsillectomy (TE) performed with electrosurgery to intracapsular approaches (SIPT) by coblation or microdebrider. The patient group is adults with recurrent or chronic tonsillitis
Detailed description
Extracapsular tonsillectomy (TE) with monopolar electrosurgery is the most commonly used approach in adult tonsil surgery in Turku University Central Hospital, Finland.
In our study setting we are comparing intracapsular tonsillectomy (subtotal/intracapsular/partial tonsillectomy (SIPT) ) as the intervention group with extracapsular tonsillectomy as the control group.
SIPT is done with either coblation or microdebrider and TE with monopolar electrosurgery.
Indications for surgery are recurrent tonsillitis or chronic tonsillitis. The patient group is adults (16-65 years)
Safety, efficiency and cost-effectiveness are monitored in a prospective, patient-blinded and randomised study setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- prospective, single-blinded, randomised, controlled
| Arm | Type | Receives |
|---|---|---|
| ECTE/Electrosurgery | Active comparator | Procedure: tonsillectomyExtracapsular tonsillectomy (ECTE) with monopolar electrosurgery |
| ICTE/Microdebrider | Experimental | Procedure: tonsillectomyIntracapsular tonsillectomy (ICTE) with microdebrider |
| ICTE/Coblator | Experimental | Procedure: tonsillectomyIntrapsular tonsillectomy (ICTE) with coblator |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 16-65 years
- Planned tonsil surgery with informed consent
- Recurrent or chronic tonsillitis
Key exclusion criteria (11 listed)
- Less than 1 month old, drained quinsy
- Acute "hot phase" tonsillitis
- Previous palatine tonsil surgery
- Suspicion or confirmation of malignancy
- High dose analgesics consumption
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 |
|---|---|---|
| tonsillectomyAlso: tonsil removal, tonsil surgeryremoval of tonsil tissue as described in the study arms | Procedure or surgery | ECTE/Electrosurgery, ICTE/Coblator, ICTE/Microdebrider |
Primary outcome
Post-operative recovery
Time frame: 21 days
Pain post-operatively after discharge as self-reported pain intensity over the past day. Each day is scored with the modified Brief Pain Inventory and recovery is achieved when pain score reaches preset values. Recovery speed defined as pain VAS-score 3 or less at rest; or pain VAS-score 5 or less without regular analgesics use. Daily questionnaire used: Brief Pain Inventory.
7 secondary outcomes
Analgesics use
Time frame: 21 days
Post-operative bleeding
Time frame: 21 days
Life Quality
Time frame: 6 months
Residual tonsil tissue
Time frame: 6 months
Revision surgery
Time frame: 5 years
Throat problems
Time frame: 5 years
Life quality
Time frame: 6 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 10 Sep 2025.
- Background: PubMed 36104143Piitulainen JM, Uusitalo T, Sjoblom HM, Ivaska LE, Jegoroff H, Kauko T, Kokki H, Kyto E, Mansikka I, Ylikoski J, Jero J. Intracapsular tonsillectomy in the treatment of recurrent and chronic tonsillitis in adults: a protocol of a prospective, single-blinded, randomised study with a 5-year follow-up (the FINITE trial). BMJ Open. 2022 Sep 14;12(9):e062722. doi: 10.1136/bmjopen-2022-062722.
- Derived from this study: PubMed 41954901Uusitalo T, Sjoblom H, Ivaska LE, Kauko T, Kokki H, Mansikka I, Kyto E, Piitulainen J. Intracapsular vs Extracapsular Tonsillectomy Recovery Time: The FINITE Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Jun 1;152(6):552-559. doi: 10.1001/jamaoto.2026.0284.
- Individual participant dataSharing planned: Yes. All data relevant to the study are included in the article or uploaded as supplementary information.
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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.
Jussi Jero, Professor study director
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tonsillectomy in people with Tonsil Disease and Tonsillitis, run by Turku University Hospital at 1 site in Finland.
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 3 inclusion and 11 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 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
Post-operative recovery (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03654742, which also lists 2 linked publications.
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 10 Sep 2025.