Trial document




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  DRKS00020823

Trial Description

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Title

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

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Trial Acronym

TOTO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

For the removal of palatal tonsils, two surgical procedures are currently used as standard in medicine. One is a partial removal of the palatal tonsils (tonsillotomy), the other is a complete removal of the palatal tonsils (tonsillectomy). Partial removal is mainly performed in small children with respiratory problems. Complete removal of the palatine tonsils, on the other hand, has been the standard treatment for recurrent acute tonsillitis.
It has not yet been clarified whether a tonsillotomy is inferior to a tonsillectomy in patients with recurrent acute tonsillitis for whom the treating physician would recommend surgery. The aim of this study is to clarify this question.

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Brief Summary in Scientific Language

The Gemeinsame Bundesauschuss (G-BA) (Joint Federal Committee) has initiated a call for tenders for the testing of tonsillotomy (TT) in recurrent acute tonsillitis (RAT) as a so-called pilot study because it has not yet been possible to clarify with sufficient evidence whether TT is inferior to tonsillectomy (TE) in patients with RAT and an indication for surgery.
This study is intended to clarify this question. Thus a randomized, multicentre, two-arm, unblinded non-inferiority study will be conducted in which an experimental surgical approach (TT) will be compared with a standard approach (TE).
To prove the non-inferiority, the primary hypothesis is that the frequency of sore throat within 24 months after TT is not higher than after TE. At the same time, it is expected that TT has lower risks compared to TE not only in the short term but also in the long term until 24 months after surgery.
The study is relevant for children ≥ 3 years and adults with RAT.
If a TT is not inferior in terms of the benefits of the TE and has at least the same or lower risks and postoperative morbidity, the TT could replace the TE for this surgical segment. This would lead to a significant reduction in healthcare costs. A reduction in morbidity would lead to an additional significant reduction in health care costs.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

Together with primary results the anonymised dataset will be published

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Organizational Data

  •   DRKS00020823
  •   2020/09/08
  •   [---]*
  •   yes
  •   Approved
  •   2020-1839-BO, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   J03 -  Acute tonsillitis
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Interventions/Observational Groups

  •   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 non-luxurious condition
    the tonsils will be partially removed down to the level of behavior of the palatal arch, so
    that from the ground up the remaining tonsil no longer protrudes over the palatal arches.

    Follow-up per patient: 24 months after surgery
  •   Tonsillectomy (TE); 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
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Number of symptomatic inflammations in the throat and pharynx area within 24 months after surgery

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Secondary Outcome

• 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/10/01
  •   454
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   no maximum age
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Additional 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. 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])
4. 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]);
5.Tonsil size - Brodsky Grade 1;
6.Operational procedure indicated and patient is operable

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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

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Addresses

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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    • Universitätsmedizin Göttingen, Studienzentrum
    • Mr.  Ralf  Tostmann 
    • Von-Bar-Str. 2/4
    • 37075  Göttingen
    • Germany
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    • Universitätsklinikum JenaKlinik und Poliklinik für HAls Nasen- und Ohrenheilkunde
    • Mr.  Prof. Dr. med.  Orlando  Guntinas-Lichius 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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    • Universitätsklinikum JenaKlinik und Poliklinik für Hals-. Nasen- und Ohrenheilkunde
    • Ms.  Dr.  Katharina  Geißler 
    • Am Klinikum 1
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss
    • Gutenbergstraße 13
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.