Sublingual Microcirculation and Postoperative Ileus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01828047|
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Inflammatory Bowel Diseases Gastrointestinal Dysfunction||Device: orthogonal polarization spectral (OPS) imaging|
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
- Is there a correlation between peri-operative microcirculatory flow measurements and the duration of symptomatic primary POI?
- 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?
- 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?
|Study Type :||Observational|
|Actual Enrollment :||34 participants|
|Official Title:||Correlation Between Sublingual Microcirculation and Postoperative Ileus Symptoms in Patients Undergoing Colorectal Surgery - a Pilot Study|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Elective colorectal surgeries
Patients undergoing elective colorectal procedures with an Enhanced Recovery Program. Orthogonal polarization spectral (OPS) imaging will be used to measure sublingual microcirculation
Device: orthogonal polarization spectral (OPS) imaging
orthogonal polarization spectral (OPS) imaging allows noninvasive observation of human microcirculation in all accessible tissue surfaces
- Postoperative ileus symptoms; microvascular flow index (MFI) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828047
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator:||Gabriele Baldini, MD, MSc||McGill University|