Left-sided Colorectal Resection : Colonic Neoplasms, Left-sided Colorectal Resection : Diverticular Diseases, Left-sided Colorectal Resection : Rectal Neoplasms
Conditions
Keywords
Colorectal surgery, TRIDENT system, Tissue oxygenation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEuse of the TRIDENT system
usage of Trident System v1.0, just before the final resection, to obtain some images of the tissue oxygenation.
Sponsors
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for a left-sided colorectal resection, irrespective of the surgical approach (open surgery, laparoscopic surgery,) because of: * Colon cancer OR * Sigmoid diverticular disease OR * Rectal cancer * All genders * Age \> 18 years old * Ability to understand the information related to the study protocol
Exclusion criteria
* Pregnancy or breastfeeding * Contraindications to anaesthesia * Inability to provide a written informed consent * Inclusion in a different ongoing clinical trial * Emergency procedure * Abdomino-perineal resection * Hartmann procedure * Patient is part of vulnerable population (e.g., prisoners, mentally disabled)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery. | 30 days FU | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - 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. | surgery day | 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. |
Countries
France
Outcome results
None listed