Tonsillectomy versus tonsillotomy in children and adults with recurrent acute tonsillitis:a controlled, randomized non-inferiority - TOTO

niversitätsklinikum Jena0 个研究点目标入组 454 人开始时间: 2020年9月8日最近更新: 2024年8月19日

适应症

试验速览

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•1. Written declaration of consent or declaration of consent of the legal guardian and/or legal representative;
•2. Age of 3 years (36 months);
•3. Sufficient knowledge of German to read and understand the patient information and related consent forms, as well as to read, understand and answer the self-report data collection questions (also in follow-up).
•4. 6 reported episodes of a medically diagnosed and antibiotic-treated purulent tonsillitis/pharyngotonsillitis within the last twelve months (indication position in accordance with the AWMF guideline Inflammatory diseases of the palate tonsils/ tonsillitis, therapy [Register number: 017-024])
•5. or 3-5 episodes if within the next 6 months
•further episodes should occur and the number 6 is reached or, if the additional patient-specific factors: special personal or professional concern, severe complaints during the episodes, individual patient request (Indication position in accordance with the AWMF guideline Inflammatory
•Diseases of the palate tonsils/ tonsillitis, therapy
•[Register number: 017-024]);
•6.Tonsil size - Brodsky Grade 1;
•7.Operational procedure indicated and patient is operable

•Other diseases of the palatine tonsils, including hyperplasia without tonsillitis/pharyngotonsillitis, peritonsillary abscess, status after peritonsillary abscess, craniofacial dysmorphism, malignant diseases, bleeding disorder, pregnancy
•Tonsillitis due to causes other than those mentioned, including infectious mononucleosis
•Pregnant or nursing mothers

发起方

niversitätsklinikum Jena