Tonsillectomy versus tonsillotomy in children and adults with recurrent acute tonsillitis:a controlled, randomized non-inferiority
- Conditions
- J03Acute tonsillitis
- Registration Number
- DRKS00020823
- Lead Sponsor
- niversitätsklinikum Jena
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 454
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of symptomatic inflammations in the throat and pharynx area within 24 months after surgery
- Secondary Outcome Measures
Name Time Method • Number of symptomatic inflammations in the throat and pharynx area within 12 months after surgery<br>• Number of days with incapacity to work or to attend kindergarten/school 6 months, 12 months, 18 months and 24 months after surgery<br>• Tonsil and Adenoid Health Status Instrument (TAHSI) questionnaire (version for children or adults), Tonsillectomy Outcome Inventory (TOI-14) and general quality of life questionnaire (SF-12) before surgery, 6 months, 12 months, 18 months, 24 months after surgery<br>