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


- candidate number9371
- NTR NumberNTR2873
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-apr-2011
- Secondary IDsP10.001 METC LUMC
- Public TitleIntra-operatieve fluorescente beeldvorming van anastomoses bij gastro-intestinale chirurgie.
- Scientific TitleIntraoperative fluorescence imaging of anastomoses in gastro-intestinal surgery.
- ACRONYMGREEN LIGHT
- hypothesisFluorescent near-infrared imaging can assess tissue perfusion in the area of the anastomosis.
- Healt Condition(s) or Problem(s) studiedPatients who undergo major surgery, Gastro-intestinal anastomosis
- Inclusion criteriaPatients undergoing surgery in which a gastro-intestinal anastomosis is made.
- Exclusion criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2011
- planned closingdate1-mei-2012
- Target number of participants36
- InterventionsPatients 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 our experimental camerasystem.
- Primary outcomeTissue perfusion.
- Secondary outcomeThe correlation between tissue perfusion and anastomosis patency.
- TimepointsTissue perfusion will be assessed directly after injection of ICG.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. C.J.H. Velde, van de
- CONTACT for SCIENTIFIC QUERIESMD PhD A.L. Vahrmeijer
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), KWF Kankerbestrijding
- PublicationsN/A
- Brief summaryAnastomotic leakage still remains a major problem in gasto-intestinal surgery. Intraoperative assessment of tissue perfusion is still difficult. Near-infrared fluorescent (NIRF) imaging is a recently developed method to visualize tissue perfusion during surgery. Patients will receive standard of care. After resection, the near-infrared dye ICG will be injected i.v. and tissue perfusuon will be visualized non-invasively and using our experimental camerasystem.
- Main changes (audit trail)
- RECORD27-apr-2011 - 8-mei-2011


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