Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis

Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis: A Randomized Controlled Non-inferiority Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Tonsillitis Recurrent
• Intervention / Treatment: Procedure: Tonsillotomy; Procedure: Tonsillectomy

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah Inez Houborg, MD; Phone Number: +45 21256818; Email: hahoub@clin.au.dk
• Study Contact Backup: Name: Tejs Ehlers Klug, MD, DMSc; Email: tejsehlersklug@hotmail.com

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital
    • Contact: Hannah I Houborg, MD; Phone Number: +4521256818; Email: hahoub@clin.au.dk
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Hannah I Houborg, MD; Phone Number: +5421256818; Email: hahoub@clin.au.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tonsillotomy; A potential non-inferior surgical procedure for treating recurrent acute tonsillitis.	Procedure: Tonsillotomy; 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.; Other Names: Intracapsular tonsillectomy; TO
Active Comparator: Tonsillectomy; The current standard surgical procedure for treating recurrent acute tonsillitis.	Procedure: Tonsillectomy; Bilateral extracapsular removal of palatine tonsils. Surgery will be performed under general anesthesia using "cold knife" dissection.; Other Names: TE; Extracapsular tonsillectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sore throat episodes after TE vs. TO.		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
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Patients will be asked the following question: "Keeping in mind your full experience and the effects of surgery so far, are you satisfied with having undergone surgery?. Possible answers are 1) "yes", 2) "no" and 3) "I don't know"	12 months (and 24, 36 and 60 months)
Postoperative Glasgow Benefit Inventory (GBI) score after TE vs. TO	A generic questionnaire for otorhinolaryngological interventions. It is used post-intervention to detect changes in quality of life. It consists of 18 questions that covers three subscales: a general health sub-scale (question 1-6, 9-10, 14, 16-18), a social support subscale (question 7, 11 and 15) and a physical health subscale (question 8, 12-13). The questionnaire uses a five-point Likert scale with 1 representing "worst change of health status" and 5 representing "best change of health status". The points are summed and divided by the number of questions (resulting in average scores), and by subtracting 3 and multiplying by 50, the final scores range from -100 to +100. 0 indicates no change, higher scores reflect better quality of life	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)

Collaborators and Investigators

• Sponsor: Tejs Ehlers Klug
• Collaborators: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; tonsillectomy; tonsillotomy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pharyngitis; Recurrence; Tonsillitis
• Other Study ID Numbers: TETO study protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No