Trial document





This trial has been registered retrospectively.
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  DRKS00018798

Trial Description

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Title

A study about the role of preoperative anxiety on surgical outcomes: A prospective observational cohort study

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Trial Acronym

PBS

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

To investigate the relationship between preoperative anxiety and postoperatve occurence of complications and all cause in-Hospital mortality

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Organizational Data

  •   DRKS00018798
  •   2019/10/08
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  •   yes
  •   Approved
  •   102/18-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   F43.2 -  Adjustment disorders
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Interventions/Observational Groups

  •   Self complition of standardized anxiety assesment questionaries (STAI, HADS, APAIS) before a scheduled surgical procedure in visceral surgery to asses state anxiety
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Preoperative anxiety

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Secondary Outcome

Occurence of postoperative complications and all cause in-hospital mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/09/10
  •   600
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Minimum Age of 18 years, informed conscent and a scheduled visceral surgical procedure for any diagnosis

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Exclusion Criteria

Age under 18 years, outpatient surgical procedures, emergent surgical procedures, cancellation of the scheduled procedure, severe psyciatric, communication and kognitive disorders, active history of alcohol and drug abuse, unable to speak german or english, non-compliance

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Addresses

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    • Chirurgische Klinik II, Universitätsklinikum der medizinischen Fakultät der Universität Leipzig
    • Ms.  Prof. Dr.  Ines  Gockel 
    • Liebig-Str. 20, Haus 4
    • 04103  Leipzig
    • Germany
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    • Chirurgische Klinik II, Universitätsklinikum der medizinischen Fakultät der Universität Leipzig
    • Mr.  PD Dr. med.  Woubet  Kassahun 
    • Liebig-Str. 20, Haus 4
    • 04103  Leipzig
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Chirurgische Klinik II, Universitätsklinikum der medizinischen Fakultät der Universität Leipzig
    • Mr.  PD Dr. med.  Woubet  Kassahun 
    • Liebig-Str. 20, Haus 4
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Chirurgische Klinik II, Medizinische Fakultät der Universität Leipzig
    • Liebig-Str. 20
    • 04103  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.