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Sublingual Microcirculation and Postoperative Ileus

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01828047
Enrollment
34
Registered
2013-04-10
Start date
2013-11-30
Completion date
2014-11-30
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Gastrointestinal Dysfunction, Inflammatory Bowel Diseases

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?

Interventions

DEVICEorthogonal polarization spectral (OPS) imaging

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

Sponsors

Gabriele Baldini, MD, MSc, Assistant Professor
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative ileus symptoms; microvascular flow index (MFI)Participants will be followed for the duration of hospital stay, an expected average of 3 daysPatients 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).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026