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


N/A
18 Years
N/A
Open (Enrolling)
Female
Colorectal Cancer, Inflammatory Bowel Diseases, Gastrointestinal Dysfunction

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Trial Information

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


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?


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Postoperative ileus symptoms; microvascular flow index (MFI)

Outcome Description:

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).

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Gabriele Baldini, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University

Authority:

Canada: Ethics Review Committee

Study ID:

12-214-SDR

NCT ID:

NCT01828047

Start Date:

February 2013

Completion Date:

September 2013

Related Keywords:

  • Colorectal Cancer
  • Inflammatory Bowel Diseases
  • Gastrointestinal Dysfunction
  • Colorectal Neoplasms
  • Inflammatory Bowel Diseases
  • Intestinal Diseases

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