Using fluorescence to assess bowel health during emergency surgery
Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 5 sites (Copenhagen, Capital Region and 4 other locations) |
| Trial ID | NCT06322862 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are experiencing acute physiological derangement and have suspected bowel ischemia.
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.
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 performed: Other studies have shown promising results using similar fluorescence-guided techniques, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Copenhagen, Capital Region and 4 other locations
- 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 — Rigshospitalet, Denmark
- Study coordinator: Sermed Ellebæk Nicolae, MD, PhD-student
- Email: sermed.nicolae@regionh.dk
- Phone: +45 3545 9666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.