Intracapsular Tonsillectomy in Adults

Sponsor

Turku University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03654742

Collaborator

(none)

200

Enrollment

Location

Arms

99.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Tonsil Disease Tonsillitis Tonsillitis Acute Tonsillitis Chronic	Procedure: tonsillectomy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, single-blinded, randomised, controlledprospective, single-blinded, randomised, controlled

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Patients are masked with numbers and patient records not shown to the outcomes assessor

Primary Purpose:

Treatment

Official Title:

Intracapsular vs Extracapsular Tonsillectomy. A Comparison of Treatment Methods of Recurrent and Chronic Tonsillitis in Adults: a Prospective Single-blinded Randomised Study

Actual Study Start Date :

Sep 27, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ECTE/Electrosurgery Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery	Procedure: tonsillectomy removal of tonsil tissue as described in the study arms Other Names: tonsil removal tonsil surgery
Experimental: ICTE/Microdebrider Intracapsular tonsillectomy (ICTE) with microdebrider	Procedure: tonsillectomy removal of tonsil tissue as described in the study arms Other Names: tonsil removal tonsil surgery
Experimental: ICTE/Coblator Intrapsular tonsillectomy (ICTE) with coblator	Procedure: tonsillectomy removal of tonsil tissue as described in the study arms Other Names: tonsil removal tonsil surgery

Arm

Intervention/Treatment

Active Comparator: ECTE/Electrosurgery

Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery

Procedure: tonsillectomy

removal of tonsil tissue as described in the study arms

Other Names:

tonsil removal

tonsil surgery

Experimental: ICTE/Microdebrider

Intracapsular tonsillectomy (ICTE) with microdebrider

Procedure: tonsillectomy

removal of tonsil tissue as described in the study arms

Other Names:

tonsil removal

tonsil surgery

Experimental: ICTE/Coblator

Intrapsular tonsillectomy (ICTE) with coblator

Procedure: tonsillectomy

removal of tonsil tissue as described in the study arms

Other Names:

tonsil removal

tonsil surgery

Outcome Measures

Primary Outcome Measures

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

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
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.
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: Glasgow Benefit Inventory "GBI" at 6 months after operation.