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Intra-operatieve fluorescente beeldvorming van anastomoses bij gastro-intestinale chirurgie.

Intraoperative fluorescence imaging of anastomoses in gastro-intestinal surgery.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26451
Enrollment
36
Registered
2011-04-27
Start date
2011-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing surgery in which a gastro-intestinal anastomosis is made.

Interventions

Patients will receive standard of care. Tissue perfusion in the area of the anastomosis will be visualized after intravenous injection of the near-infrared dye indocyanine green non-invasively using o

Sponsors

Leiden University Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing surgery in which a gastro-intestinal anastomosis is made.

Exclusion criteria

Exclusion criteria: 1. History of allergy to iodine, shellfish, indocyanine green; 2. Pregnancy; 3. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Design outcomes

Primary

MeasureTime frame
Tissue perfusion.

Secondary

MeasureTime frame
The correlation between tissue perfusion and anastomosis patency.

Contacts

Public ContactC.J.H. Velde, van de

Leiden University Medical Center (LUMC), Department of Surgical Oncology, P.O. Box 9600

c.j.h.van_de_velde@lumc.nl+31 (0)71 5262309

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)