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- Klinische proef NCT02688946
Imaging Microcirculation and Gross Hemodynamics in Elective Colorectal Surgery (IMAGES)
Imaging Microcirculation And Gross Hemodynamic Assessment of the Bowel During Elective Colorectal Surgery
Rationale: The interaction between macro and microcirculation remains uncertain. Microvascular alterations can occur when systemic hemodynamic parameters are within an acceptable range. Perfusion changes and microvascular alterations may play an important role in anastomotic healing and the onset of anastomotic leakage after gastrointestinal surgery. Nowadays, assessment of bowel perfusion is macroscopically performed by the surgeon prior to anastomosis creation. However, local oxygen delivery may still be compromised as little is known about microcirculatory alterations of the bowel during colorectal surgery. Dark Field (DF) imaging is a technique using a stroboscopic light-emitting diode ring-based imaging modality incorporated in a hand-held device, which illuminates an area of interest and provides high contrast dynamic images of the microvasculature. DF-imaging enables to visualize the bowel's microcirculation.
Objective: To describe the human gastrointestinal microcirculation during gastrointestinal surgery under general anesthesia and to observe whether there is a correlation between bowel microcirculation and systemic hemodynamic parameters.
Study design: A prospective, single center, observational, clinical, pilot study.
Study population: 70 patients undergoing elective, gastrointestinal surgery during which the gastrointestinal tract is accessible for DF-imaging.
Main study parameters/endpoints: To describe human gastrointestinal microcirculation on both the serosal and mucosal side of the bowel during gastrointestinal surgery under general anesthesia. Main parameter: Microvascular perfusion is quantified using the Microvascular Flow Index (MFI).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The extend of burden and risk associated with participation is negligible. Using DF imaging on the bowel is a non-invasive technique requiring a minimal amount of time as is described in the study procedure. Previous studies did not show any safety concerns. Measuring will be performed under sterile conditions and the occurrence of tissue damage is highly unlikely. Patients are under general anesthesia and will thus not experience any inconvenience.
Studie Overzicht
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Nieuwegein, Nederland
- St Antonius hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
70 patients undergoing elective, gastrointestinal surgery. Surgical procedures included will be:
- All forms of open colorectal surgery;
- Pylorus Persevering PancreaticoDuodenectomy (PPPD);
- Other procedures requiring small bowel resection for cancer;
- Laparoscopic procedures with extracorporeal creation of the bowel anastomosis. These procedures provide unique access to different parts of the bowel. The PPPD procedure provides access to the mucosal and serosal side of the jejunum. Colorectal surgery provides access to both the serosal and mucosal side of the colon and the terminal ileum is sometimes also accessible. We expect to include around 2 patients per week.
Beschrijving
Inclusion Criteria:
- All patients aged >18 scheduled for elective, gastrointestinal surgery (as described above) with signed informed consent.
Exclusion Criteria:
• Age <18 years;
- Atrial fibrillation (because of possible interference with FloTrac™/Vigileo™ cardiac output monitor);
- Left ventricular ejection fraction ≤30%;
- Serious pulmonary disease (resting pO2 <90% at room air);
- Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula);
- Liver failure;
- No signed informed consent.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Microvascular flow index (MFI)
Tijdsspanne: Intra-operative
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During surgery
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Intra-operative
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Perfused vessel density (PVD)
Tijdsspanne: Intra-operative
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Intra-operative
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Proportion of perfused vessels (PPV)
Tijdsspanne: Intra-operative
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Intra-operative
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Total vessel density (TVD)
Tijdsspanne: Intra-operative
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Intra-operative
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Heterogeneity index (HI)
Tijdsspanne: During surgery
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During surgery
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mat Van Iterson, PhD, St. Antonius Hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- NL4833210014
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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