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Active, Not Recruiting

NCT Number: NCT03654742

Intracapsular Tonsillectomy in Adults

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tonsil Disease Body Temperature Changes Heat Stress Disorders Hyperthermia Infections Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Stomatognathic Diseases Tonsillitis Tonsillitis Acute Tonsillitis Chronic Wounds and Injuries

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TYKS Korvaklinikka

Turku, 20521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tonsillectomy

Procedure

removal of tonsil tissue as described in the study arms

Other names: tonsil removal, tonsil surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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;

  4. Residual tonsil tissue

    Time frame: 6 months

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

  5. Revision surgery

    Time frame: 5 years

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

  6. Throat problems

    Time frame: 5 years

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

  7. Life quality

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

Intracapsular vs Extracapsular Tonsillectomy. A Comparison of Treatment Methods of Recurrent and Chronic Tonsillitis in Adults: a Prospective Single-blinded Randomised Study

Important dates

Study start
2019
Primary completion
2023
Study completion
2028
First posted
Aug 31, 2018
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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