Trial document




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  DRKS00009640

Trial Description

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Title

Tonsillectomy versus Tonsillotomy in adults with recurrent acute Tonsillitis: a prospective randomised study

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Longterminvestigation after total and partiell resection of the Palatine tonsils

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Brief Summary in Scientific Language

Prospective and randomised Investigation of adults with tonsillectomy and tonsillotomy over 2 years postoperative

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Organizational Data

  •   DRKS00009640
  •   2015/11/17
  •   [---]*
  •   yes
  •   Approved
  •   EK-BR-78/15-1, Ethikkommission bei der Sächsischen Landesärztekammer
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Secondary IDs

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

  •   J35.0 -  Chronic tonsillitis
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Interventions/Observational Groups

  •   Tonsillectomy
  •   Tonsillotomy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Early and late postoperative bleeding after tonsillectomy vs. tonsillotomy

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Secondary Outcome

Evaluation of the outcomes 12 and 24 month after tonsillotomy considering recurrent Tonsillitis/necessary tonsillectomy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/05/10
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

recurrent Tonsillitis Paradise-criteria

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Exclusion Criteria

acute tonsillitis, peritonsillar abscess, malignoms abnormal in history bleedings drug-/alcoholabuse incompliance

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Addresses

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    • Sana Kliniken Leipziger Land GmbH Sana Klinikum Borna Klinik für Hals-, Nasen- Ohrenheilkunde, Kopf-/Hals- und plastische Gesichtschirurgie
    • Mr.  Dr. med.  Jan  Wittlinger 
    • Rudolf-Virchow-Strasse 2
    • 04552  Leipzig
    • Germany
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    • Sana Kliniken Leipziger Land GmbH Sana Klinikum Borna Klinik für Hals-, Nasen- Ohrenheilkunde, Kopf-/Hals- und plastische Gesichtschirurgie
    • Mr.  Dr. med  Jan  Wittlinger 
    • Rudolf-Virchow-Strasse 2
    • 04552  Leipzig
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Sana Kliniken Leipziger Land GmbH Sana Klinikum Borna Klinik für Hals-, Nasen- Ohrenheilkunde, Kopf-/Hals- und plastische Gesichtschirurgie
    • Mr.  Dr. med.  Jan  Wittlinger 
    • Rudolf-Virchow-Strasse 2
    • 04552  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Sana Kliniken Leipziger Land GmbH Sana Klinikum Borna Klinik für Hals-, Nasen- Ohrenheilkunde, Kopf-/Hals- und plastische Gesichtschirurgie
    • Rudolf-Virchow-Strasse 2
    • 04552  Leipzig
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.