Intracapsular Tonsillectomy in Adults
- Conditions
- Tonsillitis AcuteTonsillitisTonsil DiseaseTonsillitis Chronic
- Interventions
- Procedure: tonsillectomy
- Registration Number
- NCT03654742
- Lead Sponsor
- Turku University Hospital
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 167
- Age 16-65 years
- Planned tonsil surgery with informed consent
- Recurrent or chronic tonsillitis
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ECTE/Electrosurgery tonsillectomy Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery ICTE/Coblator tonsillectomy Intrapsular tonsillectomy (ICTE) with coblator ICTE/Microdebrider tonsillectomy Intracapsular tonsillectomy (ICTE) with microdebrider
- Primary Outcome Measures
Name Time Method Post-operative recovery 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 Outcome Measures
Name Time Method Life quality 6 months Quality of life as defined by the questionnaires: Glasgow Benefit Inventory "GBI" at 6 months after operation.
Analgesics use 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.
Post-operative bleeding 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
Revision surgery 5 years The need of revision surgery after tonsillectomy, recorded with questionnaire: Nordic Tonsil Surgery Register
Throat problems 5 years Throat problems as described by the Nordic Tonsil Surgery Register at different time points postoperatively
Life Quality 6 months Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 "TOI-14" preoperatively and 6 months after operation;
Residual tonsil tissue 6 months Residual tonsil measured right after surgery is completed and at 6 months follow-up.
Trial Locations
- Locations (1)
TYKS Korvaklinikka
🇫🇮Turku, Finland