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The objective of the study is to assess the safety and technical feasibility of a new imaging system, used during colorectal resection surgery, named Trident in version 1.0, which could be used by the surgeon during colorectal procedures to obtain information on intestinal tissue oxygenation.
This is a prospective, non-randomized, single center, feasibility trial. All consecutive patients that fulfil the inclusion/exclusion criteria will be informed about the possibility to be included in the present clinical investigation. Only subjects that have signed the study informed consent will be included in the study. The Trident System v1.0 will be used only during approximately 2 to 5 minutes during a precise surgical step, i.e., just before the final resection of the surgical specimen. Patients will be prospectively followed at 30 days post-surgery. Data will be collected prospectively from the medical records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interventional arm (use of TRIDENT system) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| use of the TRIDENT system | Device | usage of Trident System v1.0, just before the final resection, to obtain some images of the tissue oxygenation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery. | descriptive analysis on the quality images by the engineering design team and feedback provided by clinical experts (surgeons) according to ad hoc form evaluating: 1) ergonomics aspects; 2) workflow; 3) risks of breaching sterility; 4) Speed of image acquisition. | 30 days FU |
| Measure | Description | Time Frame |
|---|---|---|
| - level of oxygenation (StO2) of the exteriorized colon before resection with the Trident System v1.0 - the level of oxygenation (StO2) provided by the system at the site chosen by the surgeon based on the clinical evaluation. | Measurement of StO2 values at the resection site determined by the surgeon based on his clinical judgment and measurement of StO2 levels over the entire length of the colon exteriorized and visible in the field of view of the Trident System v1.0. |
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Inclusion Criteria:
Patient scheduled for a left-sided colorectal resection, irrespective of the surgical approach (open surgery, laparoscopic surgery,) because of:
All genders
Age > 18 years old
Ability to understand the information related to the study protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier Mutter, MD, PhD | CHU Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Strasbourg | Strasbourg | France |
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| surgery day |