Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06322862

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Complete this quick 3-step screening to check your eligibility

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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

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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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