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Intracapsular Tonsillectomy in Adults

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ClinicalTrials.gov Identifier: NCT03654742
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 11, 2022
Sponsor:
Information provided by (Responsible Party):
Jaakko Piitulainen, 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

Condition or disease Intervention/treatment Phase
Tonsil Disease Tonsillitis Tonsillitis Acute Tonsillitis Chronic Procedure: tonsillectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, 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 : September 27, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 30, 2027


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




Primary Outcome Measures :
  1. Post-operative recovery [ Time Frame: 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 :
  1. Analgesics use [ Time Frame: 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.

  2. Post-operative bleeding [ Time Frame: 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

  3. Life Quality [ Time Frame: 6 months ]
    Quality of life as defined by the questionnaires: Tonsillectomy Outcome Inventory 14 "TOI-14" preoperatively and 6 months after operation;

  4. Residual tonsil tissue [ Time Frame: 6 months ]
    Residual tonsil measured right after surgery is completed and at 6 months follow-up.

  5. Revision surgery [ Time Frame: 5 years ]
    The need of revision surgery after tonsillectomy, recorded with questionnaire: Nordic Tonsil Surgery Register

  6. Throat problems [ Time Frame: 5 years ]
    Throat problems as described by the Nordic Tonsil Surgery Register at different time points postoperatively

  7. Life quality [ Time Frame: 6 months ]
    Quality of life as defined by the questionnaires: Glasgow Benefit Inventory "GBI" at 6 months after operation.



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654742


Contacts
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Contact: Tapani J. Uusitalo, M.D. 0405069070 ext +358 uusitalotapani@gmail.com

Locations
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Finland
TYKS Korvaklinikka Recruiting
Turku, Finland, 20521
Contact: Tapani J Uusitalo, MD    0405069070 ext +358    uusitalotapani@gmail.com   
Contact: Jaakko Piitulainen, MD PhD    0408373612 ext +358    jaakko.piitulainen@tyks.fi   
Sponsors and Collaborators
Turku University Hospital
Investigators
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Study Director: Jussi Jero, Professor Turku University Hospital
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Responsible Party: Jaakko Piitulainen, Consultant, Turku University Hospital
ClinicalTrials.gov Identifier: NCT03654742    
Other Study ID Numbers: T211/2018
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data relevant to the study are included in the article or uploaded as supplementary information.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will become available with the publication of the article

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaakko Piitulainen, Turku University Hospital:
tonsil surgery
tonsillectomy
intracapsular
microdebrider
coblation
extracapsular
electrosurgery
electrocautery
adults
Additional relevant MeSH terms:
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Tonsillitis
Pharyngitis
Respiratory Tract Infections
Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases