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Imaging Microcirculation and Gross Hemodynamics in Elective Colorectal Surgery

Imaging Microcirculation And Gross Hemodynamic Assessment of the Bowel During Elective Colorectal Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02688946
Acronym
IMAGES
Enrollment
70
Registered
2016-02-23
Start date
2014-05-31
Completion date
2016-12-01
Last updated
2018-03-06

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

Conditions

Microcirculation

Brief summary

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.

Interventions

Sponsors

St. Antonius Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Microvascular flow index (MFI)Intra-operativeDuring surgery

Secondary

MeasureTime frame
Perfused vessel density (PVD)Intra-operative
Proportion of perfused vessels (PPV)Intra-operative
Total vessel density (TVD)Intra-operative
Heterogeneity index (HI)During surgery

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026