FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Indocyanine green: Intraoperative perfusion assessment with ICG Fluorescence Angiography (ICG-FA) in standard approved doses

Study summary

This is a prospective, multicentre, non-randomized cohort study using real-time intraoperative visualization of bowel perfusion by indocyanine green (ICG) in all-cause bowel ischemia.

At intraoperative finding of bowel ischemia, the initial intraoperative plan is noted and resection margins marked with a steril pen. A fluorescence angiography will be performed and the surgeon will note whether the suspected ischemic bowel is perfused, whether there is a change in the resection margins in centimeters, and if the intraoperative plan has changed. If resection is indicated and the strategy of choice is an anastomosis, a renewed fluorescence angiography will be performed to assess anastomotic perfusion.

Eligibility

Primary outcome measure(s)

• Change of strategy — Assessed at day 30 and 90 after surgery
  Change of intraoperative strategy due to ICG fluorescence angiography. Intraoperatively, a nurse will record the initial strategy, indication of resection in centimeters, before and after ICG angiography, and note whether there has been a change in strategy, and how.

Trial sites (5)

More Copenhagen University Hospital, Rigshospitalet trials in Denmark