Anastomotic leakage
Conditions
Interventions
All patients will undergo the standard-of-care program which includes perfusion
assessment by the surgical eye. In addition to this standard-of-care,
2D-perfusion maps will be generated of the gastr
Sponsors
LIMIS Development bv
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All patients with a clinical suspicion and diagnosis of benign or malignant, small or large bowel lesions requiring surgical resection and any bariatric patients undergoing bypass surgery (Roux-en-Y gastric bypass).
Exclusion criteria
Exclusion criteria: No vulnerable population will be included in this investigation. - Medical or psychiatric conditions that compromise the patient*s ability to give informed consent; - Breastfeeding or pregnant population
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Efficiency of PerfusiX-imaging compared indocyanine green fluorescence imaging for intestinal perfusion imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence of any adverse event (adverse events will be summarized descriptively and formulations on the type, severity and relationship with regards to the device will be performed) - We will assess the feasibility by monitoring the technically successful completion of intended perfusion visualization. The ability of PerfusiX-Imaging to display perfusion (yes/no) - Usability of Perfusix-Imaging (ease of setup, latency of display, quality of perfusion display, concordance/discordance with surgical eye-based/ICG-based assessments, support personnel satisfaction). - Related patient information will be recorded (height, weight, BMI, HB-value, blood pressure and heart rate during imaging procedures) | — |
Countries
Netherlands
Outcome results
None listed