Correlation Between Sublingual Microcirculation and Postoperative Ileus Symptoms in Patients Undergoing Colorectal Surgery - a Pilot Study
AIM OF THE STUDY This observational study will assess whether perioperative microcirculatory
changes can be correlated with symptoms associated with primary POI.
PRIMARY RESEARCH QUESTION Is there a correlation between peri-operative microcirculatory
flow measurements and the incidence of symptomatic primary POI?
SECONDARY RESEARCH QUESTIONS
1. Is there a correlation between peri-operative microcirculatory flow measurements and
the duration of symptomatic primary POI?
2. If any correlation is observed, which anatomic location (sublingual mucosa vs bowel
serosa) yields microcirculatory flow measurements that are more strongly associated
with the incidence and/or duration of symptomatic primary POI?
3. Can either intraoperative sublingual mucosa or intraoperative bowel serosa
microcirculatory flow measurements predict symptoms of primary POI? Are these two
anatomic locations equivalent in their ability to predict this complication?
Observational
Observational Model: Cohort, Time Perspective: Prospective
Postoperative ileus symptoms; microvascular flow index (MFI)
Patients will be considered having POI symptoms if at least one symptom, for each of the following criteria, will be reported: i. Vomiting (+/- nausea) OR abdominal distension AND ii. Absence of passing gas/stool OR not tolerating oral diet. Microvascular flow index (MFI) score: this score is based on determination of the predominant type of flow observed. Flow is characterized as absent (0), intermittent (1), sluggish (2), or normal (3).
Participants will be followed for the duration of hospital stay, an expected average of 3 days
No
Gabriele Baldini, MD, MSc
Principal Investigator
McGill University
Canada: Ethics Review Committee
12-214-SDR
NCT01828047
February 2013
September 2013
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