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OpenTrials
Completed

NCT Number: NCT02688946

Imaging Microcirculation and Gross Hemodynamics in 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Antonius Hospital

Nieuwegein, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Not provided

Other

Primary outcomes

  1. Microvascular flow index (MFI)

    Time frame: Intra-operative

    During surgery

Secondary outcomes

  1. Perfused vessel density (PVD)

    Time frame: Intra-operative

  2. Proportion of perfused vessels (PPV)

    Time frame: Intra-operative

  3. Total vessel density (TVD)

    Time frame: Intra-operative

  4. Heterogeneity index (HI)

    Time frame: During surgery

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

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

Acronym: IMAGES

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 23, 2016
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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