NCT06322862 FLuorescence Guided Assessment of Mesenteric Ischemia in Emergency Surgery
| NCT ID | NCT06322862 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Bowel; Ischemic, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-03-05 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Sermed Ellebæk Nicolae, MD, PhDstudent
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT06322862 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bowel; Ischemic, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06322862 currently recruiting?
Yes, NCT06322862 is actively recruiting participants. Contact the research team at sermed.nicolae@regionh.dk for enrollment information.
Where is the NCT06322862 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Bispebjerg, Denmark, Herlev, Denmark, Hillerød, Denmark and 1 additional location.
Who is sponsoring the NCT06322862 clinical trial?
NCT06322862 is sponsored by Rigshospitalet, Denmark. The principal investigator is Sermed Ellebæk Nicolae, MD, PhDstudent at Rigshospitalet, Denmark. The trial plans to enroll 100 participants.