Symptoms and General Pathology

All Conditions

Anastomotic Leak

Postoperative Complications

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients who can be treated with either PME or TME and receive a primary anastomosis during surgery.

Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis

Quantitative Indocyanine Green Fluorescence Angiography

Carolin Oppermann, MD

Niclas Dohrn, MD

Ismail Gögenur, DMSc, MD

Mads Falk Klein, PhD, MD

Fluorescence angiography with indocyanine green (ICG-FA) has gained increased popularity in colorectal surgery to check perfusion to the newly-formed anastomotic area and decrease the rate of postoperative anastomotic leakage.

While qualitative ICG assessment has the advantage to be used instantly during the operative procedure, it does bear drawbacks (subjective assessment, dependent on factors like camera distance, ICG dose and white-light contamination).

The alternative is quantitative ICG assessment, which is performed by evaluating the time-intensity curve of the ICG-FA with an external analyzing software. The procedure is showing promising results, but the methodology is still reported very heterogeneously.

This study is a multi-center, prospective, standardized, surgeon-blinded observational trial. The key aspect of this study is the non-interventional design with blinding of both the qualitative and quantitative results from the ICG perfusion measurement, providing no chance of influencing the course of the operation. Assessment of perfusion will be performed postoperatively blinded to the outcome. Assessment of the pre-anastomotic area is intraoperatively performed by an image analysis software that then calculates a perfusion score based on an algorithm integrating relevant perfusion metrics. The primary outcome is the combined rate of early and late anastomotic complications within 90 days postoperatively.

Quantitative ICG Fluorescence Angiography in Colorectal Surgery

Quantitative ICG Fluorescence Angiography in Colorectal Surgery (QUANTICO): A Protocol for a Prospective, Standardized, Observational, Surgeon-blinded Multi-center Trial

combined rate of all anastomotic complications

obstipation and intolerance of oral intake due to nonmechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal surgery

surgical complication in which a wound ruptures along a surgical incision

Number of patients had have to be readmitted to the hospital due to postoperative complications

Continuous ECG-monitoring intraoperatively and postoperatively

Perfusion Tech Aps

Zealand University Hospital

Medical Doctor, PhD student

Digestive System Diseases

Diverticulitis

Diverticulum

Diverticular Diseases

Gastroenteritis

Gastrointestinal Diseases

Pathological Conditions, Anatomical

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.

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.

Left-sided colonic resection

Didier Mutter, MD, PhD

Michele Diana, MD

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.

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.

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

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.

The intraoperative intestinal perfusion on the anastomosis site, measured by fluorescence videography, will be correlated to the rate of anastomosis leakage.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Quantitative ICG Fluorescence Angiography in Colorectal Surgery	NCT05153954	Colorectal Canc... Anastomotic Lea...	Quantitative In...	18 Years -	Zealand University Hospital
Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis	NCT02626091	Sigmoid Diverti... Sigmoid Diverti... Colorectal Mali...	Left-sided colo...	18 Years -	IHU Strasbourg

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