Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis

Conditions
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Sigmoid Diverticulosis, Sigmoid Diverticulitis, Colorectal Malignancy

Intervention / Treatment
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* Procedure: Left-sided colonic resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perfusion evaluation of anastomosis<br>During left-sided colonic resections, anastomosis perfusion will be estimated by the visual appreciation of the surgeon and the ICG fluorescence-based enhanced reality. These two approaches will be compared. | Procedure: Left-sided colonic resection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the perfusion evaluated by the ICG fluorescence-based enhanced reality and the metabolic state of the intestine | 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. | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the intraoperative intestinal perfusion and the rate of anastomosis leakage | The intraoperative intestinal perfusion on the anastomosis site, measured by fluorescence videography, will be correlated to the rate of anastomosis leakage. | During surgery | 
| 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 | 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. | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anastomotic perfusion, ICG Fluorescence, Enhanced reality, Left-sided colonic resection