Trial document




drksid header

  DRKS00014863

Trial Description

start of 1:1-Block title

Title

Comparison of the "anterior-superior tympanoplasty" and the "U-spring tympanoplasty" for the reconstruction of anterior and subtotal defects of the tympanic membrane

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

Trial Acronym

[---]*

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

[---]*

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

Brief Summary in Scientific Language

The most effective surgical technique for the reconstruction of anterior and subtotal defects of the tympanic membrane is still a matter of debate. Posterior defects can be reconstructed with a success rate of around 95%. In contrast, success rates of anterior defects are reported as low as 67%. Published data on the outcomes after tympanoplasty usually rely on retrospective analysis of single methods. The techniques used in this study, i.e. the “anterior-superior tympanoplasty” and the “U-spring tympanoplasty” have not been described yet in detail.
Accordingly, the main goal of our prospective study is to compare both tympanoplasty techniques for the closure of anterior and subtotal defects of the tympanic membrane and evaluate their audiological outcome.

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

Organizational Data

  •   DRKS00014863
  •   2018/06/08
  •   [---]*
  •   yes
  •   Approved
  •   51_18 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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

  •   H66.9 -  Otitis media, unspecified
  •   H73.8 -  Other specified disorders of tympanic membrane
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   anterior- superior tympanoplasty
  •   U-spring tympanoplasty
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
  •   Parallel
  •   IV
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary endpoint of the study is the successfull reconstruction of anterior and subtotal defects of the tympanic Membrane and the audiological outcome (otoscopic and audiometric examination) 6, 12 and 24 monnths after surgery.

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

Secondary Outcome

[---]*

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

Countries of Recruitment

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

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2018/06/18
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- All patients 18 yrs of a age or older that exhibit an anterior or subtotal defect of the tympanic membrane. Additionally, the ossicular chain is intakt. All patients referred to the ENT clinic at the university of Erlangen.

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

Exclusion Criteria

Patients that refuse to give their approval to participate in the study and those who suffer from diseases of the cartilage and/or skin.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • HNO Uniklinik Erlangen
    • Waldstrasse 1
    • 91341  Erlangen
    • 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 scientific-contact
    • HNO Uniklinik Erlangen
    • Mr.  PD  Antoniu-Oreste  Gostian 
    • Waldstrasse 1
    • 91054  Erlangen
    • 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 Uniklinik Erlangen
    • Mr.  PD  Antoniu-Oreste  Gostian 
    • Waldstrasse 1
    • 91054  Erlangen
    • 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-Universitätsklinik Erlangen
    • Mr.  Pd  Antoniu - Oreste  Gostian 
    • Waldstrasse 1
    • 91054  Erlangen
    • 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 planned
  •   [---]*
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.