Sublingual Microcirculation and Postoperative Ileus

Sponsor
Gabriele Baldini, MD, MSc, Assistant Professor (Other)
Overall Status
Completed
CT.gov ID
NCT01828047
Collaborator
(none)
34
1
12
2.8

Study Details

Study Description

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 Phase
  • 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?

Study Design

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 :
Nov 1, 2013
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Postoperative ileus symptoms; microvascular flow index (MFI) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montreal General Hospital Montreal Quebec Canada H3G 1A4

Sponsors and Collaborators

  • Gabriele Baldini, MD, MSc, Assistant Professor

Investigators

  • Principal Investigator: Gabriele Baldini, MD, MSc, McGill University

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Apr 10, 2013
Last Update Posted:
Mar 17, 2015
Last Verified:
Mar 1, 2015
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2015