Sublingual Microcirculation and Postoperative Ileus

Gabriele Baldini, MD, MSc, Assistant Professor34 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Cancer Inflammatory Bowel Diseases Gastrointestinal Dysfunction

Interventions

orthogonal polarization spectral (OPS) imagingDEVICE

orthogonal polarization spectral (OPS) imaging allows noninvasive observation of human microcirculation in all accessible tissue surfaces

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Montreal General Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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).

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

Data from ClinicalTrials.gov

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