Intracapsular Tonsillectomy in Adults

September 3, 2025 updated by: Jaakko Piitulainen, Turku University Hospital

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20521
        • TYKS Korvaklinikka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ECTE/Electrosurgery
Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery
Procedure: tonsillectomy
removal of tonsil tissue as described in the study arms
Other Names:
  • tonsil removal
  • tonsil surgery
Experimental: ICTE/Microdebrider
Intracapsular tonsillectomy (ICTE) with microdebrider
Procedure: tonsillectomy
removal of tonsil tissue as described in the study arms
Other Names:
  • tonsil removal
  • tonsil surgery
Experimental: ICTE/Coblator
Intrapsular tonsillectomy (ICTE) with coblator
Procedure: tonsillectomy
removal of tonsil tissue as described in the study arms
Other Names:
  • tonsil removal
  • tonsil surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesics use
Time Frame: 21 days
Need for analgesics postoperatively during 21 days. Measured as number of naprometin tablets/ day and the number of tramadol-paracetamol combination tablets/day.
21 days
Post-operative bleeding
Time Frame: 21 days
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
21 days
Life Quality
Time Frame: 6 months
Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 "TOI-14" preoperatively and 6 months after operation;
6 months
Residual tonsil tissue
Time Frame: 6 months
Residual tonsil measured right after surgery is completed and at 6 months follow-up.
6 months
Revision surgery
Time Frame: 5 years
The need of revision surgery after tonsillectomy, recorded with questionnaire: Nordic Tonsil Surgery Register
5 years
Throat problems
Time Frame: 5 years
Throat problems as described by the Nordic Tonsil Surgery Register at different time points postoperatively
5 years
Life quality
Time Frame: 6 months
Quality of life as defined by the questionnaires: Glasgow Benefit Inventory "GBI" at 6 months after operation.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Study Director: Jussi Jero, Professor, Turku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2019

Primary Completion (Actual)

January 5, 2023

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T211/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Data will become available with the publication of the article

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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