Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis

NCT06606262 | Recruiting

• 1 other identifier: TETO study protocol
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

Background: recurrent acute tonsillitis (RT) is a frequent condition affecting teenagers and adults. Patients suffer from recurring throat symptoms, fever and impaired quality of life (QOL). Tonsillectomy (TE) is the only well-known treatment, but studies indicate that tonsillotomy (TO) is associated with less morbidity (eg. pain and bleeding) and equal efficiency (e.g. reduced number of sore throat episodes and improved QOL). The investigator aim to clarify whether TO is a non-inferior alternative to TE. Methods: inclusion and randomization of 250 adult RT patients for TE or TO with a 12 month follow up. Comparisons will be made between groups, and outcome measures includes number of sore throat episodes, QOL and postoperative pain. Discussion: the study has the potential to improve the treatment of a prevalent disease by enhancing knowledge of an alternative procedure (TO) associated with less discomfort and risk than the current standard procedure (TE) and a presumably low risk of insufficiency.

Conditions

Tonsillitis Recurrent

Keywords

tonsillectomy; tonsillotomy; quality of life

Outcome Measures

Primary Outcomes (4)

• Number of sore throat episodes after TE vs. TO.

  12 months (and 24, 36 and 60 months)

• QOL measured as postoperative Tonsillectomy Outcome Inventory 14 (TOI-14) score after TE vs. TO

  A disease-specific questionnaire for adults with tonsillitis. It is used pre- and postoperatively to detect changes in quality of life. It consists of 14 questions that covers four subscales: throat dis-comfort (question 1-4) general health (question 5-6), resources (question 7-10), and social psychological restrictions (question 11-14). The questionnaire uses a six-point Likert scale with 0 representing "no problem" and 5 representing "couldn't be worse". The points are summed, divided by the number of questions multiplied by 5, and multiplied by 100, giving scores in the range 0-100, where higher scores reflect poorer quality of life

  12 months (and 24, 36 and 60 months)

• Summarized postoperative pain scores (days 1-10)

  Measured on a numeric rating scale from 0 til 10 in which 0 represents "no pain" and 10 represents "excruciating pain"

  Days 1-10

• Overall postoperative discomfort (day 21)

  Measured on a numeric rating scale from 0 til 10 in which 0 represents "no discomfort" and 10 represents "excruciating discomfort"

  Day 21

Secondary Outcomes (5)

• Proportion of patients cured (defined as postoperative TOI-14<15) after TE vs. TO

  12 months (and 24, 36 and 60 months)

• Overall patient satisfaction after TE vs. TO

  12 months (and 24, 36 and 60 months)

• Postoperative Glasgow Benefit Inventory (GBI) score after TE vs. TO

  12 months (and 24, 36 and 60 months)

• Number of sore throat days after TE vs. TO

  12 months (and 24, 36 and 60 months)

• Prevalence of reoperation after TE vs. TO

  12 months (and 24, 36 and 60 months)

Study Arms (2)

Tonsillotomy

EXPERIMENTAL

A potential non-inferior surgical procedure for treating recurrent acute tonsillitis.

Procedure: Tonsillotomy

Tonsillectomy

ACTIVE COMPARATOR

The current standard surgical procedure for treating recurrent acute tonsillitis.

Procedure: Tonsillectomy

Interventions

Tonsillotomy PROCEDURE

Bilateral partial removal of the palatine tonsils to a level between the pharyngeal pillars and the tonsillar capsule. Surgery will be performed under general anesthesia using monopolar electrocautery.

Also known as: Intracapsular tonsillectomy, TO

Tonsillotomy

Tonsillectomy PROCEDURE

Bilateral extracapsular removal of palatine tonsils. Surgery will be performed under general anesthesia using "cold knife" dissection.

Also known as: Extracapsular tonsillectomy, TE

Tonsillectomy

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age ≥15 years) with RT, defined as a minimum of five tonsillitis episodes in one year or a minimum of three tonsillitis episodes per year for two years (Danish National Guidelines criteria
• The ability to understand Danish orally and in writing.

You may not qualify if:

• Previous TE or TO.
• Suspected tonsillar malignancy.
• History of malignant tumor in the oral cavity, the pharynx or the larynx.
• Previous radiation therapy on head or neck.
• Hemorrhagic diathesis or anticoagulant therapy.

Sponsors & Collaborators

• Tejs Ehlers Klug: lead
• University of Aarhus: collaborator

Study Sites (2)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Interventions

Tonsillectomy

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Hannah Inez Houborg, MD

CONTACT

+45 21256818; hahoub@clin.au.dk

Tejs Ehlers Klug, MD, DMSc

CONTACT

tejsehlersklug@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, DMSc, Clinical Associate Professor

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 20, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)