NCT03654742

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Sep 2019Dec 2028

First Submitted

Initial submission to the registry

August 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 27, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2023

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Expected
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

August 29, 2018

Last Update Submit

September 3, 2025

Conditions

Tonsil DiseaseTonsillitisTonsillitis AcuteTonsillitis Chronic

Keywords

tonsil surgerytonsillectomyintracapsularmicrodebridercoblationextracapsularelectrosurgeryelectrocauteryadults

Outcome Measures

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.

    21 days

Secondary Outcomes (7)

  • Analgesics use

    21 days

  • Post-operative bleeding

    21 days

  • Life Quality

    6 months

  • Residual tonsil tissue

    6 months

  • Revision surgery

    5 years

  • +2 more secondary outcomes

Study Arms (3)

ECTE/Electrosurgery

ACTIVE COMPARATOR

Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery

Procedure: tonsillectomy

ICTE/Microdebrider

EXPERIMENTAL

Intracapsular tonsillectomy (ICTE) with microdebrider

Procedure: tonsillectomy

ICTE/Coblator

EXPERIMENTAL

Intrapsular tonsillectomy (ICTE) with coblator

Procedure: tonsillectomy

Interventions

tonsillectomyPROCEDURE

removal of tonsil tissue as described in the study arms

Also known as: tonsil removal, tonsil surgery
ECTE/ElectrosurgeryICTE/CoblatorICTE/Microdebrider

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TYKS Korvaklinikka

Turku, 20521, Finland

Location

Related Publications (1)

  • 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.

    PMID: 36104143BACKGROUND

MeSH Terms

Conditions

TonsillitisHyperthermia

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jussi Jero, Professor

    Turku University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patients are masked with numbers and patient records not shown to the outcomes assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, single-blinded, randomised, controlled
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

August 29, 2018

First Posted

August 31, 2018

Study Start

September 27, 2019

Primary Completion

January 5, 2023

Study Completion (Estimated)

December 30, 2028

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

All data relevant to the study are included in the article or uploaded as supplementary information.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will become available with the publication of the article

Locations

FI(1)