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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04314492
Other study ID # T62/2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date December 2029

Study information

Verified date November 2023
Source Turku University Hospital
Contact Henrik M. Sjöblom, M.D.
Phone 023130000
Email hmsjob@utu.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2029
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility 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 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


Intervention

Procedure:
Tonsillectomy
Intracapsular removal of tonsillar tissue (>90%) with coblation

Locations

Country Name City State
Finland Satasairaala Pori Satakunta
Finland Turku University Hospital Turku Varsinais-Suomi

Sponsors (1)

Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other Apnea-hypopnea index Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography. 24 months
Other Apnea-hypopnea index Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography. 60 months
Primary Apnea-hypopnea index Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography. 6 months
Secondary Quality of life measured by Glasgow Benefit Inventory General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better. 6 months and 24 month and 60 months
Secondary Quality of life measured by Nordic tonsil surgery register questionnaire Questions regarding postoperative complications and perceived symptom relief after 180 days. Yes/no questions and open questions, no score. 6 months - up to 5 years
Secondary Quality of life measured by Epworth sleepiness scale Questions regarding sleepiness. Score 0-24, lower is better. 6 months - up to 5 years
Secondary Post-operative recovery Recovery speed defined as score 3 or less at rest; or 5 or less without regular analgesics use, questionnaire used: Brief Pain Inventory. 21 days
Secondary Total recovery of obstructive sleep apnea Defined by apnea-hypopnea index <5 post-operatively in polysomnography. 6 months and 24 months and 60 months
Secondary Regrowth of tonsillar tissue Measured by photography, Friedman scale (0-4, lower is smaller). Pre-operative to 6 months
Secondary Apnea-index Post-operative apnea index reduction by 50% compared to preoperative values in polysomnography. 6 months and 24 months and 60 months
Secondary Snoring time Post-operative reduction of snoring time in preoperative polysomnography compared to post-operative values in 6 months and 24 months and 60 months
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