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Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis

NCT ID: NCT06606262

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tonsillitis Recurrent

Keywords

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tonsillectomy tonsillotomy quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tonsillotomy

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

Group Type EXPERIMENTAL

Tonsillotomy

Intervention Type 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.

Tonsillectomy

The current standard surgical procedure for treating recurrent acute tonsillitis.

Group Type ACTIVE_COMPARATOR

Tonsillectomy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Tonsillectomy

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

Intervention Type PROCEDURE

Other Intervention Names

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Intracapsular tonsillectomy TO Extracapsular tonsillectomy TE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

Tejs Ehlers Klug

OTHER

Sponsor Role lead

Responsible Party

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Tejs Ehlers Klug

MD, DMSc, Clinical Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Hannah Inez Houborg, MD

Role: CONTACT

Phone: +45 21256818

Email: [email protected]

Tejs Ehlers Klug, MD, DMSc

Role: CONTACT

Email: [email protected]

Facility Contacts

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Hannah I Houborg, MD

Role: primary

Hannah I Houborg, MD

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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TETO study protocol

Identifier Type: -

Identifier Source: org_study_id