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Active, not recruitingNCT03654742Updated Sep 10, 2025

Intracapsular Tonsillectomy in Adults

An interventional study of tonsillectomy in Tonsil Disease, Tonsillitis and Tonsillitis Acute, sponsored by Turku University Hospital. Active, not recruiting at 1 site in Finland. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Turku University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tonsil Disease
  • Tonsillitis
  • Tonsillitis Acute
  • Tonsillitis Chronic

Keywords

  • tonsil surgery
  • tonsillectomy
  • intracapsular
  • microdebrider
  • coblation
  • extracapsular
  • electrosurgery
  • electrocautery
  • adults
03

In context

Tonsillitis

103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.

This study's enrollment of 167 is above the median of 100 across 87 interventional studies indexed under Tonsillitis.

Browse Tonsillitis studies →

Lead sponsor

Turku University Hospital is the lead sponsor of 287 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 16-65 years
  • Planned tonsil surgery with
  • Recurrent or chronic tonsillitis

Exclusion criteria

Exclusion Criteria:

  • Less than 1 month old, drained quinsy
  • Acute "hot phase" tonsillitis
  • Previous palatine tonsil surgery
  • Suspicion or confirmation of
  • High dose analgesics consumption
  • Current CPAP-device usage for treatment of OSAS
  • 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
167 participants (actual)

Study arms

  • Active comparator
    ECTE/Electrosurgery

    Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery

    Procedure: tonsillectomy

  • Experimental
    ICTE/Microdebrider

    Intracapsular tonsillectomy (ICTE) with microdebrider

    Procedure: tonsillectomy

  • Experimental
    ICTE/Coblator

    Intrapsular tonsillectomy (ICTE) with coblator

    Procedure: tonsillectomy

Interventions

  • Proceduretonsillectomy

    removal of tonsil tissue as described in the study arms

    Also known as: tonsil removal, tonsil surgery

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 21 days

Secondary outcomes

  1. 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.

    Time frame: 21 days

  2. 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

    Time frame: 21 days

  3. Life Quality

    Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 "TOI-14" preoperatively and 6 months after operation;

    Time frame: 6 months

  4. Residual tonsil tissue

    Residual tonsil measured right after surgery is completed and at 6 months follow-up.

    Time frame: 6 months

  5. Revision surgery

    The need of revision surgery after tonsillectomy, recorded with questionnaire: Nordic Tonsil Surgery Register

    Time frame: 5 years

  6. Throat problems

    Throat problems as described by the Nordic Tonsil Surgery Register at different time points postoperatively

    Time frame: 5 years

  7. Life quality

    Quality of life as defined by the questionnaires: Glasgow Benefit Inventory "GBI" at 6 months after operation.

    Time frame: 6 months

07

Study locations

1 site
  • TYKS Korvaklinikka
    Turku, 20521, Finland
08

References and documents

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 36104143 ↗
  • Uusitalo 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 ↗

Individual participant data

Plan to share: Yes — All data relevant to the study are included in the article or uploaded as supplementary information.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data will become available with the publication of the article

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03654742
Responsible party
Jaakko Piitulainen (Consultant, Turku University Hospital) — Principal investigator
First posted
Aug 31, 2018
Start date
Sep 27, 2019
Primary completion
Jan 5, 2023
Completion
Dec 30, 2028 (estimated)
Last update
Sep 10, 2025

Study contacts

Jussi Jero, Professor
study director · Turku University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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