Actively Recruiting
FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery
Led by Rigshospitalet, Denmark · Updated on 2024-11-15
100
Participants Needed
5
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients over 18 years of age
- Suspected bowel ischemia with acute physiologic derangement
- Intraoperative confirmation of all-cause bowel ischemia with acute physiologic derangement
You will not qualify if you...
- Allergy to iodine, indocyanine green, or shellfish
- Liver insufficiency
- Thyrotoxicosis
- Pregnancy or lactation
- Permanently legally incompetent for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Department of Organ Surgery and Transplantation
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
2
Department of Surgery, Bispebjerg Hospital
Bispebjerg, Denmark
Actively Recruiting
3
Department of Surgery, Herlev Hospital
Herlev, Denmark
Actively Recruiting
4
Department of Surgery, Nordsjællands Hospital
Hillerød, Denmark
Actively Recruiting
5
Department of Surgery, Hvidovre Hospital
Hvidovre, Denmark
Actively Recruiting
Research Team
S
Sermed Ellebæk Nicolae, MD, PhD-student
CONTACT
M
Michael Patrick Achiam, MD, PhD, DMSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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