J03
Conditions
Interventions
Group 1: Tonsillotomy (TT)
The operative intervention can also be a done by an
Adenotomy (AT)
Outpatient treatment or inpatient treatment for about 1-
3 days.
The extent of the partial distance is specified as follows:
In
In addition, the surgical procedure can also be a
Include an adenotomy (AT).
Inpatient treatment for about 5 days
Follow up per patient 24 months after surgery
Sponsors
Universitätsklinikum Jena
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of symptomatic inflammations in the throat and pharynx area within 24 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number of symptomatic inflammations in the throat and pharynx area within 12 months after surgery • Number of days with incapacity to work or to attend kindergarten/school 6 months, 12 months, 18 months and 24 months after surgery • 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 | — |
Countries
Germany
Contacts
Public ContactKatharina Geißler
Universitätsklinikum JenaKlinik und Poliklinik für Hals-. Nasen- und Ohrenheilkunde
Outcome results
None listed