Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-01-02
2021-06-20
Brief Summary
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Detailed Description
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As Standard in our clinical Routine the tissue perfusion is measured with fluorescence Imaging and Indocyaningreen (ICG). In this study the investigators use the Hyperspectral-Camera (HSI-Camera) as new method. The measurements were performed like described before, using the TIVITA Tissue system (Diaspective Vision GmbH, Am Salzhaff, Germany). This HSI-camera provides hyperspectral images with a high spectral resolution (5 nm) in the visible and near infrared range (500-1000 nm). A RGB image and 4 false color images that represent physiologic parameters are intraoperatively provided by an analysis software. This work is focused on tissue oxygenation (StO2), which represents the relative blood oxygenation in the microcirculation of superficial tissue layers (approximately 1 mm) and the near-infrared (NIR) Perfusion Index, representing tissue layers in 4-6 mm penetration depth.
As Standard method ICG-Fluorescence Imaging is used. After the procedure the Perfusion data of both Systems is compared.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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ICG
Fluorescence imaging for blood Perfusion of the gastrointestinal tissue
Indocyaningreen-Fluorescence imaging
Photos were taken with the Fluorescence camera after injection of the indocyaningreen-dye of the gastrointestinal anastomosis
HSI
Hyperspectralimaging for blood Perfusion of the gastrointestinal tissue
Hyperspectral-Imaging
Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.
Interventions
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Hyperspectral-Imaging
Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.
Indocyaningreen-Fluorescence imaging
Photos were taken with the Fluorescence camera after injection of the indocyaningreen-dye of the gastrointestinal anastomosis
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* allergy against indocyaningreen dye
18 Years
ALL
Yes
Sponsors
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University of Leipzig
OTHER
Responsible Party
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Dr. Boris Jansen-Winkeln
Principal Investigator, Deputy Head of Department, Priv.-Doz. Dr. med. habil.
Principal Investigators
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Boris Jansen-Winkeln, MD, PD
Role: PRINCIPAL_INVESTIGATOR
University of Leipzig
Locations
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Universitätsklinikum Leipzig - AöR
Leipzig, Saxony, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Jansen-Winkeln B, Holfert N, Kohler H, Moulla Y, Takoh JP, Rabe SM, Mehdorn M, Barberio M, Chalopin C, Neumuth T, Gockel I. Determination of the transection margin during colorectal resection with hyperspectral imaging (HSI). Int J Colorectal Dis. 2019 Apr;34(4):731-739. doi: 10.1007/s00384-019-03250-0. Epub 2019 Feb 2.
Jansen-Winkeln B, Maktabi M, Takoh JP, Rabe SM, Barberio M, Kohler H, Neumuth T, Melzer A, Chalopin C, Gockel I. [Hyperspectral imaging of gastrointestinal anastomoses]. Chirurg. 2018 Sep;89(9):717-725. doi: 10.1007/s00104-018-0633-2. German.
Jansen-Winkeln B, Germann I, Kohler H, Mehdorn M, Maktabi M, Sucher R, Barberio M, Chalopin C, Diana M, Moulla Y, Gockel I. Comparison of hyperspectral imaging and fluorescence angiography for the determination of the transection margin in colorectal resections-a comparative study. Int J Colorectal Dis. 2021 Feb;36(2):283-291. doi: 10.1007/s00384-020-03755-z. Epub 2020 Sep 23.
Other Identifiers
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202001
Identifier Type: -
Identifier Source: org_study_id
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