Intracapsular Tonsillectomy in Adults

N/AActive Not RecruitingNCT03654742

Turku University Hospital167 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

167

Conditions

Tonsil Disease Tonsillitis Tonsillitis Acute Tonsillitis Chronic

Interventions

tonsillectomyPROCEDURE

removal of tonsil tissue as described in the study arms

Eligibility

Sex: ALLMin age: 16 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

TYKS Korvaklinikka

Turku, Finland

Outcomes

Primary Outcomes

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.

Time frame: 21 days

Secondary Outcomes

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.

Time frame: 21 days

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

Time frame: 21 days

Life Quality

Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 "TOI-14" preoperatively and 6 months after operation;

Time frame: 6 months

Residual tonsil tissue

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

Time frame: 6 months

Revision surgery

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

Time frame: 5 years

Data from ClinicalTrials.gov

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