Sublingual Microcirculation and Postoperative Ileus

Completed

• Conditions: Colorectal Cancer; Inflammatory Bowel Diseases; Gastrointestinal Dysfunction
• Interventions: Device: orthogonal polarization spectral (OPS) imaging

• Registration Number: NCT01828047
• Lead Sponsor: Gabriele Baldini, MD, MSc, Assistant Professor

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?

Study Timeline

• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-10
• Study Start: 2013-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elective colorectal surgeries	orthogonal polarization spectral (OPS) imaging	Patients undergoing elective colorectal procedures with an Enhanced Recovery Program. Orthogonal polarization spectral (OPS) imaging will be used to measure sublingual microcirculation

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada