Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses

Not Applicable

• Conditions: Surgical Anastomosis
• Interventions: Procedure: Hyperspectral Imaging

• Registration Number: NCT03667950
• Lead Sponsor: University of Leipzig

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-31
• Primary Completion: 2020-12
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• all gastrointestinal anastomoses

Exclusion Criteria

• inability to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hyperspectral imaging	Hyperspectral Imaging	diagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures

Primary Outcome Measures

Name	Time	Method
Anastomotic Perfusion: Tissue-Water-Index	direct during the Operation (ca. 15-20 Minutes)	Tissue-Water-Index in %: Existing water distribution in the tissue area under consideration (index value)
Anastomotic Perfusion: Near Infrared Perfusion Index	direct during the Operation (ca. 15-20 Minutes)	Near Infrared Perfusion Index in %: Relative O2 saturation of the blood immicrocircular system in deeper tissue layers (penetration depth: 4-6mm; index value)
Anastomotic Perfusion: Tissue-Hemoglobin index	direct during the Operation (ca. 15-20 Minutes)	Tissue Hemoglobin index in %: Existing hemoglobin distribution in the microcircular system of the tissue area under consideration (index value)
Anastomotic Perfusion: (Oxygenation (StO2)	direct during the Operation (ca. 15-20 Minutes)	Oxygenation (StO2) in %: Relative O2 saturation of the blood immicrocircular system in superficial tissue layers (penetration depth: approx. 1 mm)

Trial Locations

Locations (1)

Universitätsklinikum Leipzig - AöR; 🇩🇪 Leipzig, Sachsen, Germany