Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Gabriele Baldini, MD, MSc, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
The aim of this pilot study is to establish if a correlation between sub-lingual microcirculation measured by Orthogonal polarization spectral (OPS) imaging and symptoms of postoperative ileus exist in patients undergoing elective colorectal surgery.

Condition or disease Intervention/treatment
Colorectal Cancer Inflammatory Bowel Diseases Gastrointestinal Dysfunction Device: orthogonal polarization spectral (OPS) imaging

Detailed Description:

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?

Layout table for study information
Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing elective colorectal surgery with an Enhanced Recovery Program (ERP)
Criteria

Inclusion Criteria:

  • Patients older than 18 yo undergoing elective laparoscopic colorectal surgery with an Enhanced Recovery Program (ERP) at the Montreal General Hospital

Exclusion Criteria:

  • Any patient who refuses enrolment

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Gabriele Baldini, MD, MSc, Assistant Professor
Investigators
Layout table for investigator information
Principal Investigator: Gabriele Baldini, MD, MSc McGill University
Publications:

Layout table for additonal information
Responsible Party: Gabriele Baldini, MD, MSc, Assistant Professor, Assitant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01828047    
Other Study ID Numbers: 12-214-SDR
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammatory Bowel Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Gastroenteritis