RecruitingNot ApplicableNCT06322862

FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery

Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery


Sponsor

Rigshospitalet, Denmark

Enrollment

100 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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

Exclusion Criteria5

  • Allergy toward; iodine, indocyanine green, or shellfish
  • Liver insufficiency
  • Thyrotoxicosis
  • Pregnancy or lactation
  • Permanently legally incompetent for any reason

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Interventions

OTHERIndocyanine green

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


Locations(5)

Department of Organ Surgery and Transplantation

Copenhagen, Capital Region, Denmark

Department of Surgery, Bispebjerg Hospital

Bispebjerg, Denmark

Department of Surgery, Herlev Hospital

Herlev, Denmark

Department of Surgery, Nordsjællands Hospital

Hillerød, Denmark

Department of Surgery, Hvidovre Hospital

Hvidovre, Denmark

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NCT06322862