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Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses (HSIGI)

U

University of Leipzig

Status

Unknown

Conditions

Surgical Anastomosis

Treatments

Procedure: Hyperspectral Imaging

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

In this study, gastrointestinal anastomoses are examined with a hyperspectral camera.

Full description

The anastomoses were examined under standardized conditions directly after creation. 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). The distance between camera and object was 30 cm for all measurements. The Number of Effective Pixels at this distance is 640 × 480 (x-, y-axis. The resulting field of view (FOV) has the dimensions 6.4 × 4.8 cm2 and a spatial resolution of 0.1 mm/pixel. The FOV is illuminated by 8 halogen spots (20 W each). The ceiling lights and other light sources were switched off, to avoid artifacts during the measurement (approximately 10 seconds). 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • all gastrointestinal anastomoses

Exclusion criteria

  • inability to consent

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

hyperspectral imaging
Experimental group
Description:
diagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures
Treatment:
Procedure: Hyperspectral Imaging

Trial contacts and locations

1

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Central trial contact

Ines Gockel, Prof. Dr.; Boris Jansen-Winkeln, Dr.

Data sourced from clinicaltrials.gov

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