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Intracapsular Tonsillectomy in Adults

Primary Purpose

Tonsil Disease, Tonsillitis, Tonsillitis Acute

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
tonsillectomy
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsil Disease focused on measuring tonsil surgery, tonsillectomy, intracapsular, microdebrider, coblation, extracapsular, electrosurgery, electrocautery, adults

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • TYKS KorvaklinikkaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

ECTE/Electrosurgery

ICTE/Microdebrider

ICTE/Coblator

Arm Description

Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery

Intracapsular tonsillectomy (ICTE) with microdebrider

Intrapsular tonsillectomy (ICTE) with coblator

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Life Quality
Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 "TOI-14" preoperatively and 6 months after operation;
Residual tonsil tissue
Residual tonsil measured right after surgery is completed and at 6 months follow-up.
Revision surgery
The need of revision surgery after tonsillectomy, recorded with questionnaire: Nordic Tonsil Surgery Register
Throat problems
Throat problems as described by the Nordic Tonsil Surgery Register at different time points postoperatively
Life quality
Quality of life as defined by the questionnaires: Glasgow Benefit Inventory "GBI" at 6 months after operation.

Full Information

First Posted
August 29, 2018
Last Updated
August 9, 2022
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03654742
Brief Title
Intracapsular Tonsillectomy in Adults
Official Title
Intracapsular vs Extracapsular Tonsillectomy. A Comparison of Treatment Methods of Recurrent and Chronic Tonsillitis in Adults: a Prospective Single-blinded Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsil Disease, Tonsillitis, Tonsillitis Acute, Tonsillitis Chronic
Keywords
tonsil surgery, tonsillectomy, intracapsular, microdebrider, coblation, extracapsular, electrosurgery, electrocautery, adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, single-blinded, randomised, controlled
Masking
ParticipantOutcomes Assessor
Masking Description
Patients are masked with numbers and patient records not shown to the outcomes assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ECTE/Electrosurgery
Arm Type
Active Comparator
Arm Description
Extracapsular tonsillectomy (ECTE) with monopolar electrosurgery
Arm Title
ICTE/Microdebrider
Arm Type
Experimental
Arm Description
Intracapsular tonsillectomy (ICTE) with microdebrider
Arm Title
ICTE/Coblator
Arm Type
Experimental
Arm Description
Intrapsular tonsillectomy (ICTE) with coblator
Intervention Type
Procedure
Intervention Name(s)
tonsillectomy
Other Intervention Name(s)
tonsil removal, tonsil surgery
Intervention Description
removal of tonsil tissue as described in the study arms
Primary Outcome Measure Information:
Title
Post-operative recovery
Description
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 Outcome Measure Information:
Title
Analgesics use
Description
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
Title
Post-operative bleeding
Description
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
Title
Life Quality
Description
Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 "TOI-14" preoperatively and 6 months after operation;
Time Frame
6 months
Title
Residual tonsil tissue
Description
Residual tonsil measured right after surgery is completed and at 6 months follow-up.
Time Frame
6 months
Title
Revision surgery
Description
The need of revision surgery after tonsillectomy, recorded with questionnaire: Nordic Tonsil Surgery Register
Time Frame
5 years
Title
Throat problems
Description
Throat problems as described by the Nordic Tonsil Surgery Register at different time points postoperatively
Time Frame
5 years
Title
Life quality
Description
Quality of life as defined by the questionnaires: Glasgow Benefit Inventory "GBI" at 6 months after operation.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tapani J. Uusitalo, M.D.
Phone
0405069070
Ext
+358
Email
uusitalotapani@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jussi Jero, Professor
Organizational Affiliation
Turku University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
TYKS Korvaklinikka
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tapani J Uusitalo, MD
Phone
0405069070
Ext
+358
Email
uusitalotapani@gmail.com
First Name & Middle Initial & Last Name & Degree
Jaakko Piitulainen, MD PhD
Phone
0408373612
Ext
+358
Email
jaakko.piitulainen@tyks.fi

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data relevant to the study are included in the article or uploaded as supplementary information.
IPD Sharing Time Frame
Data will become available with the publication of the article
Citations:
PubMed Identifier
36104143
Citation
Piitulainen JM, Uusitalo T, Sjoblom HM, Ivaska LE, Jegoroff H, Kauko T, Kokki H, Kyto E, Mansikka I, Ylikoski J, Jero J. Intracapsular tonsillectomy in the treatment of recurrent and chronic tonsillitis in adults: a protocol of a prospective, single-blinded, randomised study with a 5-year follow-up (the FINITE trial). BMJ Open. 2022 Sep 14;12(9):e062722. doi: 10.1136/bmjopen-2022-062722.
Results Reference
derived

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Intracapsular Tonsillectomy in Adults

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