Using fluorescence to assess bowel health during emergency surgery
Official title: Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery
Run by Copenhagen University Hospital, Rigshospitalet · NCT06322862 · Data updated 2026-11-12
This study is testing if a special dye can help surgeons see if the bowel is healthy during emergency surgery for patients with suspected bowel problems, to see if it leads to better outcomes and fewer follow-up surgeries.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 5 sites (Copenhagen, Capital Region and 4 other locations) |
| Status | Recruiting |
| Started | March 5, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | November 15, 2024 |
| Trial ID | NCT06322862 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who are experiencing acute physiological derangement and have suspected bowel ischemia.
✕Probably not a fit
Patients with allergies to indocyanine green or iodine, liver insufficiency, thyrotoxicosis, pregnancy, or those who are permanently legally incompetent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the use of indocyanine green (ICG) for real-time visualization of bowel perfusion in patients undergoing emergency surgery for suspected bowel ischemia. Surgeons will assess bowel viability using fluorescence angiography during surgery, which may influence their surgical strategy and decision-making. The study aims to determine if ICG can improve outcomes by allowing for more definitive surgical procedures and reducing the need for additional surgeries. It is a prospective, multicenter, non-randomized cohort study focused on patients with acute bowel ischemia.
Why it matters
Potential benefit: If successful, this approach could lead to better surgical outcomes and fewer complications for patients with bowel ischemia.
How similar studies have gone: Other studies have shown promising results using similar fluorescence-guided techniques, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Allergy toward; iodine, indocyanine green, or shellfish * Liver insufficiency * Thyrotoxicosis * Pregnancy or lactation * Permanently legally incompetent for any reason
Where it's running
-
Department of Organ Surgery and Transplantation
Copenhagen, Capital Region, Denmark Recruiting -
Department of Surgery, Bispebjerg Hospital
Bispebjerg, Denmark Recruiting -
Department of Surgery, Herlev Hospital
Herlev, Denmark Recruiting -
Department of Surgery, Nordsjællands Hospital
Hillerød, Denmark Recruiting -
Department of Surgery, Hvidovre Hospital
Hvidovre, Denmark Recruiting
Study contacts
- Principal investigator: Sermed Ellebæk Nicolae, MD, PhDstudent — Copenhagen University Hospital, Rigshospitalet
- Study coordinator: Sermed Ellebæk Nicolae, MD, PhD-student
- Email: sermed.nicolae@regionh.dk
- Phone: +45 3545 9666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.