Sublingual Microcirculation and Postoperative Ileus

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ClinicalTrials.gov Identifier: NCT01828047

Recruitment Status : Completed

First Posted : April 10, 2013

Last Update Posted : March 17, 2015

Sponsor:

Information provided by (Responsible Party):

Gabriele Baldini, MD, MSc, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description

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.

Condition or disease	Intervention/treatment
Colorectal Cancer Inflammatory Bowel Diseases Gastrointestinal Dysfunction	Device: orthogonal polarization spectral (OPS) imaging

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

Is there a correlation between peri-operative microcirculatory flow measurements and the duration of symptomatic primary POI?
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?
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 Design

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Study Type :	Observational
Actual Enrollment :	34 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Correlation Between Sublingual Microcirculation and Postoperative Ileus Symptoms in Patients Undergoing Colorectal Surgery - a Pilot Study
Study Start Date :	November 2013
Actual Primary Completion Date :	November 2014
Actual Study Completion Date :	November 2014

Groups and Cohorts

Group/Cohort	Intervention/treatment
Elective colorectal surgeries Patients undergoing elective colorectal procedures with an Enhanced Recovery Program. Orthogonal polarization spectral (OPS) imaging will be used to measure sublingual microcirculation	Device: orthogonal polarization spectral (OPS) imaging orthogonal polarization spectral (OPS) imaging allows noninvasive observation of human microcirculation in all accessible tissue surfaces

Outcome Measures

Primary Outcome Measures :

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).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Patients undergoing elective colorectal surgery with an Enhanced Recovery Program (ERP)

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828047

Locations

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Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4

Sponsors and Collaborators

Gabriele Baldini, MD, MSc, Assistant Professor

Investigators

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Principal Investigator:	Gabriele Baldini, MD, MSc	McGill University

More Information

Publications:

Kehlet H. Multimodal approach to postoperative recovery. Curr Opin Crit Care. 2009 Aug;15(4):355-8. doi: 10.1097/MCC.0b013e32832fbbe7. Review.

Kehlet H. Postoperative ileus--an update on preventive techniques. Nat Clin Pract Gastroenterol Hepatol. 2008 Oct;5(10):552-8. doi: 10.1038/ncpgasthep1230. Epub 2008 Aug 12. Review.

Hasibeder W. Gastrointestinal microcirculation: still a mystery? Br J Anaesth. 2010 Oct;105(4):393-6. doi: 10.1093/bja/aeq236.

Bezemer R, Bartels SA, Bakker J, Ince C. Clinical review: Clinical imaging of the sublingual microcirculation in the critically ill--where do we stand? Crit Care. 2012 Jun 19;16(3):224. doi: 10.1186/cc11236. Review.

Jhanji S, Lee C, Watson D, Hinds C, Pearse RM. Microvascular flow and tissue oxygenation after major abdominal surgery: association with post-operative complications. Intensive Care Med. 2009 Apr;35(4):671-7. doi: 10.1007/s00134-008-1325-z. Epub 2008 Oct 21.

Cassina T, Santambrogio L. Microcirculation after cardiopulmonary bypass: a glance at the mesenteric mucosa. Minerva Anestesiol. 2012 Mar;78(3):288-90.

De Backer D, Dubois MJ, Schmartz D, Koch M, Ducart A, Barvais L, Vincent JL. Microcirculatory alterations in cardiac surgery: effects of cardiopulmonary bypass and anesthesia. Ann Thorac Surg. 2009 Nov;88(5):1396-403. doi: 10.1016/j.athoracsur.2009.07.002.

Wongyingsinn M, Baldini G, Charlebois P, Liberman S, Stein B, Carli F. Intravenous lidocaine versus thoracic epidural analgesia: a randomized controlled trial in patients undergoing laparoscopic colorectal surgery using an enhanced recovery program. Reg Anesth Pain Med. 2011 May-Jun;36(3):241-8. doi: 10.1097/AAP.0b013e31820d4362.

Carli F, Charlebois P, Baldini G, Cachero O, Stein B. An integrated multidisciplinary approach to implementation of a fast-track program for laparoscopic colorectal surgery. Can J Anaesth. 2009 Nov;56(11):837-42. doi: 10.1007/s12630-009-9159-x. Epub 2009 Jul 29.

Puhl G, Schaser KD, Vollmar B, Menger MD, Settmacher U. Noninvasive in vivo analysis of the human hepatic microcirculation using orthogonal polorization spectral imaging. Transplantation. 2003 Mar 27;75(6):756-61.

Rauchfuss F, Scheuerlein H, Ludewig S, Uberrück T, Heise M, Zanow J, Settmacher U. In vivo assessment of the hepatic microcirculation after mesenterico-portal bypass (REX-shunt) using orthogonal polarization spectral imaging. Liver Int. 2010 Oct;30(9):1339-45. doi: 10.1111/j.1478-3231.2010.02311.x.

De Backer D, Hollenberg S, Boerma C, Goedhart P, Büchele G, Ospina-Tascon G, Dobbe I, Ince C. How to evaluate the microcirculation: report of a round table conference. Crit Care. 2007;11(5):R101.

Vignali A, Gianotti L, Braga M, Radaelli G, Malvezzi L, Di Carlo V. Altered microperfusion at the rectal stump is predictive for rectal anastomotic leak. Dis Colon Rectum. 2000 Jan;43(1):76-82.

Trzeciak S, Rivers EP. Clinical manifestations of disordered microcirculatory perfusion in severe sepsis. Crit Care. 2005;9 Suppl 4:S20-6. Epub 2005 Aug 25. Review.

Lewis SJ, Egger M, Sylvester PA, Thomas S. Early enteral feeding versus "nil by mouth" after gastrointestinal surgery: systematic review and meta-analysis of controlled trials. BMJ. 2001 Oct 6;323(7316):773-6.

Moore FA, Feliciano DV, Andrassy RJ, McArdle AH, Booth FV, Morgenstein-Wagner TB, Kellum JM Jr, Welling RE, Moore EE. Early enteral feeding, compared with parenteral, reduces postoperative septic complications. The results of a meta-analysis. Ann Surg. 1992 Aug;216(2):172-83.

Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279. Review.

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Responsible Party:	Gabriele Baldini, MD, MSc, Assistant Professor, Assitant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier:	NCT01828047
Other Study ID Numbers:	12-214-SDR
First Posted:	April 10, 2013 Key Record Dates
Last Update Posted:	March 17, 2015
Last Verified:	March 2015

Additional relevant MeSH terms:

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Inflammatory Bowel Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Gastroenteritis

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