Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00015451

Trial Description

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Title

Hyperspecral imaging and gastrointestinal anastomoses

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Trial Acronym

HSI_ANA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

With a hyperspectral camera the light can be recorded in the wavelengths 500 and 1000 nm. We examine gastrointestinal anastomoses with this camera. Blood flow and tissue perfusion can be calculated in the evaluation of the recorded images.

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Brief Summary in Scientific Language

Hyperspectral imaging allows light to be recorded in wavelengths between 500 and 1000 nm.
From the measured light spectra, index parameters such as hemoglobin distribution, oxygen saturation, near-infrared perfusion or water index are calculated, the values of which are coded in image intensities for visualization. These values are displayed in false-color images. This allows the blood flow to the absorbed tissue.

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Organizational Data

  •   DRKS00015451
  •   2018/09/06
  •   [---]*
  •   yes
  •   Approved
  •   026/18-ek, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   U1111-1219-5584 
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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
  •   K51 -  Ulcerative colitis
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Interventions/Observational Groups

  •   Hyperspectral Imaging of gastrointestinal anastomoses direct after creation. Measure Parameters are: Oxygenation (StO2) in %, Tissue Hemoglobin index in %, Near Infrared Perfusion Index in % and Tissue-Water-Index in %.
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Characteristics

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

tissue perfusion

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Secondary Outcome

Near-infrared perfusion

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/03/21
  •   100
  •   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

gastrointestinal anastomosis

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Exclusion Criteria

emergency surgery

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Addresses

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    • Universität Leipzig - Medizinische Fakultät
    • Liebigstr. 18
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig - AöR Klinik und Poliklinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie
    • Mr.  Dr.  Boris  Jansen-Winkeln 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig - AöR Klinik und Poliklinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie
    • Mr.  Dr.  Boris  Jansen-Winkeln 
    • Liebigstr. 20
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Universität Leipzig - Medizinische Fakultät
    • Liebigstr. 18
    • 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.