Colorectal Malignancy, Sigmoid Diverticulitis, Sigmoid Diverticulosis
Conditions
Keywords
Anastomotic perfusion, ICG Fluorescence, Enhanced reality, Left-sided colonic resection
Brief summary
The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to validate the accuracy of this technique with metabolic intestinal cells changes.
Detailed description
Accurate intraoperative evaluation of peri-anastomotic gastrointestinal tract perfusion is essential to reduce the risk of anastomotic complications such as leakage or strictures. Anastomotic leakage is the most dreadful complication of colorectal resections. Intestinal microcirculation and viability is usually estimated from the color of the serosal surface, presence of peristalsis, pulsation and bleeding from the marginal arteries. This is subjective and based on the experience of the surgeon. Fluorescence videography integrates a near-infrared endoscope able to detect the signal emitted by a fluorescent dye, Indocyanine Green (ICG), which is administered by intravenous injection. Fluorescence intensity is proportional to the amount of fluorescent dye diffused in the tissue and it consequently is a surrogate marker of tissue perfusion. The hypothesis is that ICG-fluorescence guidance coupled with enhanced reality would allow a precise and rapid localization of the future anastomotic site in terms of optimal perfusion in laparoscopic colorectal resections. In patients undergoing elective left-sided colonic resection by laparoscopic approach, resection site and anastomosis perfusion will be evaluated by : * the visual appreciation of the surgeon * the fluorescence-based enhanced reality, after injection of ICG and digital process. A series of peri-operative samplings will also be carried out. In any case, the resection will be performed according to the surgeon's appreciation.
Interventions
PROCEDURELeft-sided colonic resection
During interventions, anastomosis perfusion will be estimated (outcomes: visual appreciation of the surgeon, ICG fluorescence-based enhanced reality and series of peri-operative samplings) in order to validate the accuracy of ICG fluorescence-based enhanced reality technique. In any case, the resection will be performed according to the surgeon's appreciation.
Sponsors
IHU Strasbourg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient, male or female, from 18 years old * Patient with sigmoid diverticulosis or diverticulitis * Patient with colon malignancy * Patient with rectum malignancy * Patient with no contraindication to anesthesia and to colonic resection surgery * Patient able to understand the study and to provide informed consent * Patient affiliated to the French social security system
Exclusion criteria
* Patient undergoing emergency surgery * Patient undergoing abdomino-perineal resection * Patient undergoing colonic resection without anastomosis (Hartmann's colostomy) * Patient with proven or unclear allergic reactions * Pregnancy or breast-feeding * Patient in exclusion period (determined by a previous study or in progress) * Patient in custody * Patient under guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the perfusion evaluated by the ICG fluorescence-based enhanced reality and the metabolic state of the intestine | During surgery | The perfusion evaluated by the ICG fluorescence-based enhanced reality, obtained by the digital process of the fluorescence dynamic signal, will be correlated to the metabolic state of the intestine, assessed by the measure of biological markers on several points of the intestine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the intraoperative intestinal perfusion and the rate of anastomosis leakage | During surgery | The intraoperative intestinal perfusion on the anastomosis site, measured by fluorescence videography, will be correlated to the rate of anastomosis leakage. |
| Distance between the resection site based on the surgeon's appreciation and the resection site based on the digital analysis and the peri-operative samplings | During surgery | The distance between the resection site based on the surgeon's clinic appreciation and the resection site based on the digital analysis and the level of capillary lactates and mitochondria respiratory rate on different sites will be measured. |
Countries
France
Outcome results
None listed