Trial document




drksid header

  DRKS00015628

Trial Description

start of 1:1-Block title

Title

Partial tonsillectomy as alternative to complete tonsillectomy in recurrent tonsillitis

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

RF-TO vs. TE

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This prosepctive clinicial trial should answer the question whether a partial tonsillectomy is as effective as complete tonsillectomy in patients with recurrent tonsillitis. The design of the study is intraindividual, which means one patient´s side will be completely tonsillectomized and the other side will be partial tonsillectomized. One and three years after the procedure patients will be asked by phone, which side was more often infected or caused pain and how often antibiotics had to be taken during the followup period.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Main goal of this clinical trial is to investigate the crucial question whether the partial tonsillectomy is as effective as the complete tonsillectomy in patients with recurrent tonsillitis. Partial tonsillectomy creates less downtime and less morbidity. In order to reduce the casenumber we choosed an intraindividual design: after randomization patients will be completely tonsillectomized on one side, whereas the other side will be partially tonsillectomized. Unfortunately, a double blind design is not possible, because the surgeon and post surgical examiner can see the tonsil remnants and the patients feel the difference right after the procedure in less pain on the partial tonsillectomized side. Complete tonsillectomy is a common, well known procedure for the cure of recurrent tonsillitis, therefore another control group (with no surgical intervention) is not necessary. The partial tonsillectomy will be done with the CE-certified radiofrequenncy generator CelonLAB ENT with Celon´s ProCut probes (Celon/Olympus Inc.) with 15 watts power. All tonsillectomies will be done in inflammationfree status. For primary endpoint one and three years after the procedure patients will be asked by phone, which side was more often infected and how often antibiotics had to be taken due to sore throat during the followup period.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00015628
  •   2018/10/01
  •   [---]*
  •   yes
  •   Approved
  •   347-13, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J35.0 -  Chronic tonsillitis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   complete tonsillectomy rigth or left side. One and three years after the procedure patients will be asked by phone, which side was more often infected or caused pain and how often antibiotics had to be taken during the followup period.
  •   partial tonsillectomy left or right side. One and three years after the procedure patients will be asked by phone, which side was more often infected or caused pain and how often antibiotics had to be taken during the followup period.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Episodes of sore throat on the partial tonsillectomized side and the complete tonsillectomized side one and three years after the procedure by phone interview

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Recurrent hyperplasia of the tonsil remnant one and three years after the procedure by fotodocumentation

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Austria
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/10/02
  •   200
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Indication for tonsillectomy according to the Paradise criteria; adult patients (age > 18y); enough german language knowhow for the interview.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Haemoraghic disease; previous tonsil surgery; lack of informed consent; unilateral tonsillectomy; paratonsillar abcess; pregnancy; anticoagulation; assymetric tonsils.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • HNO Zentrum Mangfall-Inn
    • Mr.  Prof. Dr. med.  Klaus  Stelter 
    • Münchener Str. 27
    • 83022  Rosenheim
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universitätsklinik und Poliklinik fürHals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie in Halle Saale
    • Mr.  PD Dr. med.  Ulrich  Kisser 
    • Ernst-Grube-Straße 40
    • 06120  Halle (Saale)
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Medizinische Universität WienUniversitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
    • Ms.  Assoc. Prof. Priv. Doz. Dr.  Claudia  Lill 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • OLYMPUS EUROPA SE & CO. KG
    • Mr.  Dr. med.  Samuel  Faran 
    • Kuehnstraße 61
    • 22045  Hamburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • HNO Zentrum Mangfall-Inn
    • Mr.  Prof. Dr. med.  Klaus  Stelter 
    • Münchener Str. 27
    • 83022  Rosenheim
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • HNO Zentrum Mangfall-Inn
    • Mr.  Prof. Dr. med.  Klaus  Stelter 
    • Münchener Str. 27
    • 83022  Rosenheim
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • HNO Zentrum Mangfall-Inn
    • Mr.  Prof. Dr. med.  Klaus  Stelter 
    • Münchener Str. 27
    • 83022  Rosenheim
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.