FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery
Recruiting now · Not applicable
Conditions studied: Bowel; Ischemic, Acute
In brief
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.
Key facts
- Study ID
- NCT06322862
- Run by
- Rigshospitalet, Denmark
- People needed
- 100
- Starts
- 2024-03-05
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2024-11-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult patients >18 years of age
- Acute physiologic derangement and suspected of having bowel ischemia
- Intraoperative finding of all-cause bowel ischemia with subsequent acute physiologic derangement
You may not qualify if…
- Allergy toward; iodine, indocyanine green, or shellfish
- Liver insufficiency
- Thyrotoxicosis
- Pregnancy or lactation
- Permanently legally incompetent for any reason
Where it is running
- Department of Organ Surgery and Transplantation — Copenhagen, Capital Region, Denmark (enrolling)
- Department of Surgery, Bispebjerg Hospital — Bispebjerg, Denmark (enrolling)
- Department of Surgery, Herlev Hospital — Herlev, Denmark (enrolling)
- Department of Surgery, Nordsjællands Hospital — Hillerød, Denmark (enrolling)
- Department of Surgery, Hvidovre Hospital — Hvidovre, Denmark (enrolling)
Full record on ClinicalTrials.gov
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