Trial document




drksid header

  DRKS00015148

Trial Description

start of 1:1-Block title

Title

Retrospective data collection in patients after hysteroscopic and laparoscopic myoma removal and prospective desire for children

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

Trial Acronym

MT_Myomentfernung

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

Data collection by means of a specific questionnaire to assess the effects of the different access routes of myoma removal on fertility and the pregnancy-related complications and the pregnancy outcome as well as the long-term follow-up after the operation

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

Brief Summary in Scientific Language

It is a retrospective data collection in approximately 2,500 patients using a specific questionnaire to assess the effects of the different access routes of myoma removal (hysteroscopic, laparoscopic and open crurgical) on fertility and pregnancy-related complications and pregnancy outcome as well as long-term follow-up after the operation.

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

Organizational Data

  •   DRKS00015148
  •   2018/07/23
  •   [---]*
  •   yes
  •   Approved
  •   261/218BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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

  •   D25 -  Leiomyoma of uterus
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients who have received hysteroscopic, laparoscopic, or open surgical removal of myoma since 2005. The patients are interviewed by means of their own questionnaire.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Effect of myoma removal on a follow-on pregnancy (e.g., pregnancy, abortion, premature birth, sectiorates, risk of uterine rupture, etc.). Retrospective recording.

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

  •   Actual
  •   2018/07/16
  •   2500
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients who have received hysteroscopic, laparoscopic, or open surgical removal of myoma since 2005.

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

Exclusion Criteria

- Age under 18 years
- lack of patient consent

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Forschungsinstitut für FrauengesundheitDepartment für Frauengesundheit
    • Calwerstrasse 7
    • 72076  Tübingen
    • 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
    • Department für Frauengesundheit
    • Mr.  Prof Dr. med.  Bernhard  Krämer 
    • Calwerstrasse 7
    • 72076  Tübingen
    • 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
    • Department für Frauengesundheit
    • Mr.  Prof Dr. med.  Bernhard  Krämer 
    • Calwerstrasse 7
    • 72076  Tübingen
    • 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
    • Forschungsinstitut für FrauengesundheitDepartment für Frauengesundheit
    • Calwerstrasse 7
    • 72076  Tübingen
    • 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.