Идёт набор NCT06606262

Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis

Без фазы С лечением Tonsillitis Recurrent

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Tonsillotomy, Tonsillectomy.
Кому может быть актуально: Состояния в реестре: Tonsillitis Recurrent. Базовые параметры: от 15 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Дания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

Number of sore throat episodes after TE vs. TO. [Срок оценки: 12 months (and 24, 36 and 60 months)]
QOL measured as postoperative Tonsillectomy Outcome Inventory 14 (TOI-14) score after TE vs. TO [Срок оценки: 12 months (and 24, 36 and 60 months)]
Summarized postoperative pain scores (days 1-10) [Срок оценки: Days 1-10]
Overall postoperative discomfort (day 21) [Срок оценки: Day 21]

Вторичные конечные точки (5)

Proportion of patients cured (defined as postoperative TOI-14<15) after TE vs. TO [Срок оценки: 12 months (and 24, 36 and 60 months)]
Overall patient satisfaction after TE vs. TO [Срок оценки: 12 months (and 24, 36 and 60 months)]
Postoperative Glasgow Benefit Inventory (GBI) score after TE vs. TO [Срок оценки: 12 months (and 24, 36 and 60 months)]
Number of sore throat days after TE vs. TO [Срок оценки: 12 months (and 24, 36 and 60 months)]
Prevalence of reoperation after TE vs. TO [Срок оценки: 12 months (and 24, 36 and 60 months)]

Критерии участия

Критерии включения

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.