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Clinical Trials/NCT01828047
NCT01828047
Completed
Not Applicable

Correlation Between Sublingual Microcirculation and Postoperative Ileus Symptoms in Patients Undergoing Colorectal Surgery - a Pilot Study

Gabriele Baldini, MD, MSc, Assistant Professor1 site in 1 country34 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Gabriele Baldini, MD, MSc, Assistant Professor
Enrollment
34
Locations
1
Primary Endpoint
Postoperative ileus symptoms; microvascular flow index (MFI)
Status
Completed
Last Updated
11 years ago

Overview

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.

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?

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
November 2014
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Gabriele Baldini, MD, MSc, Assistant Professor
Responsible Party
Sponsor Investigator
Principal Investigator

Gabriele Baldini, MD, MSc, Assistant Professor

Assitant Professor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility 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

Outcomes

Primary Outcomes

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).

Study Sites (1)

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