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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03654742
Other study ID # T211/2018
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 27, 2019
Est. completion date December 30, 2028

Study information

Verified date November 2023
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 167
Est. completion date December 30, 2028
Est. primary completion date January 5, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility 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 Design


Intervention

Procedure:
tonsillectomy
removal of tonsil tissue as described in the study arms

Locations

Country Name City State
Finland TYKS Korvaklinikka Turku

Sponsors (1)

Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Analgesics use 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
Secondary Post-operative bleeding 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
Secondary Life Quality Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 "TOI-14" preoperatively and 6 months after operation; 6 months
Secondary Residual tonsil tissue Residual tonsil measured right after surgery is completed and at 6 months follow-up. 6 months
Secondary Revision surgery The need of revision surgery after tonsillectomy, recorded with questionnaire: Nordic Tonsil Surgery Register 5 years
Secondary Throat problems Throat problems as described by the Nordic Tonsil Surgery Register at different time points postoperatively 5 years
Secondary Life quality Quality of life as defined by the questionnaires: Glasgow Benefit Inventory "GBI" at 6 months after operation. 6 months
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