NCT02626091

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: IHU Strasbourg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sigmoid Diverticulosis
• Sigmoid Diverticulitis
• Colorectal Malignancy

Interventions

Type	Name	Description
PROCEDURE	Left-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.

Timeline

• Start date: 2016-09-14
• Primary completion: 2018-09-14
• Completion: 2018-09-14
• First posted: 2015-12-10
• Last updated: 2021-02-12

Locations

1 site across 1 country: France