Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses

NCT ID: NCT03667950

Last Updated: 2019-10-31

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Surgical Anastomosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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hyperspectral imaging

diagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures

Group Type EXPERIMENTAL

Hyperspectral Imaging

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all gastrointestinal anastomoses

Exclusion Criteria

* inability to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Dr. Boris Jansen-Winkeln

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Boris Jansen-Winkeln, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Locations

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Universitätsklinikum Leipzig - AöR

Leipzig, Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Boris Jansen-Winkeln, Dr.

Role: CONTACT

+49-314-97 ext. 17200

Ines Gockel, Prof. Dr.

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 29637244 (View on PubMed)

Other Identifiers

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HSIGI

Identifier Type: -

Identifier Source: org_study_id

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