Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

Last updated: November 22, 2023
Sponsor: Turku University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

Tonsillectomy

Clinical Study ID

NCT04314492
T62/2020
  • Ages 16-65
  • All Genders

Study Summary

Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age 16-64
  • Planned tonsil surgery with informed concent
  • Obstructive sleep apnea (AHI > 15)
  • Tonsillar size of 3-4 on the Friedman scale

Exclusion

Exclusion Criteria:

  • BMI > 35 (Based on finnish Käypä Hoito -recommendations)
  • Central sleep apnea
  • Weight loss of more than 10% within the study period
  • Untreated obstruction of nasal breathing
  • Treated peritonsillar abscess <1 month before enrollment
  • Active tonsillar infection
  • Previous tonsillar surgery (excluding incision of abscess)
  • Malignancy
  • High use of analgesics >1 DDD daily during last 4 weeks
  • Untreated reflux
  • Anticoagulative medication
  • Any condition of hemophilia
  • Pregnancy, lactation
  • Other, evaluated by treating physician

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Tonsillectomy
Phase:
Study Start date:
September 01, 2020
Estimated Completion Date:
December 31, 2029

Study Description

The investigators aim to study if good surgical results can be achieved by intracapsular tonsillectomy with coblation while monitoring safety, efficiency and cost-effectiveness. In adult tonsil surgery, the current practice in Finland is commonly extracapsular tonsillectomy with monopolar electrosurgery.

Connect with a study center

  • Satasairaala

    Pori, Satakunta 28500
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku, Varsinais-Suomi 20521
    Finland

    Active - Recruiting

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