Trial document





This trial has been registered retrospectively.
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  DRKS00016062

Trial Description

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Title

Psychovegetative reactions in main surgeon and assistance interactions as an indicator of failure frequency and complication rates in the operation theatre

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Operators are equipped with event recorders for measuring heart rate, skin resistance and ECG intraoperatively. Then the surgeons will be accompanied during a HütTEP operation. Corresponding data are then evaluated retrospectively with the corresponding events in order to determine a qualitative statement about the stress experience during a hip replacement OP.
The surgeons fill in standardized questionnaires before and after surgery.

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Brief Summary in Scientific Language

Clinical Trial - To determine how much stress within surgery affects the duration of an operation. For this, the surgeons are asked about their stress levels before and after the operation and measured during the operation using event recorders (HF IMP etc.).

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Organizational Data

  •   DRKS00016062
  •   2019/05/16
  •   [---]*
  •   yes
  •   Approved
  •   82/17, Ethik-Kommission der Universität Ulm
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Secondary IDs

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

  •   F43.0 -  Acute stress reaction
  •   I10.0 -  [generalization I10: Essential (primary) hypertension]
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Interventions/Observational Groups

  •   Clinical Trial - To determine how much stress within surgery affects the duration of an operation. For this, the surgeons are asked about their stress levels before and after the operation and measured during the operation using event recorders (HF IMP etc.).
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   [---]*
  •   [---]*
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Primary Outcome

The primary endpoint of the study is to be a total of 25 operations, each involving 2 operators.
The purpose of the endpoint is to demonstrate measurable differences in heart rate, skin resistance, and cardiac variability as a sign of stress related to certain preoperative stressors, as well as intraoperative stressors.
It states that there are measurable differences between well-rested, non-stressed previous days and pers. Findings according to questionnaires are available to stressed operators, as well as differences due to operational events influencing the measured variables.

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Secondary Outcome

Measurements should be completed in 18 months.
This is the secondary endpoint with 18 months duration. Then there is definitely an evaluation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/01/03
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   65   Years
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Additional Inclusion Criteria

Surgeon is a specialist in orthopedics and traumatology
Assistant at least continuing education assistant for surgery - including doctor

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Exclusion Criteria

No more age than 65, electrical cardial devices

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Bundeswehrkrankenhaus Ulm
    • Mr.  Dr. med.  Kevin  Dallacker-Losensky 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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    • Bundeswehrkrankenhaus Ulm
    • Mr.  Dr. med.  Kevin  Dallacker-Losensky 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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    • Bundeswehrkrankenhaus Ulm
    • Mr.  Dr. med.  Kevin  Dallacker-Losensky 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Bundeswehrkrankenhaus Ulm
    • Mr.  Dr. med.  Kevin  Dallacker-Losensky 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/12/31
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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.