Sublingual Microcirculation and Postoperative Ileus

NCT01828047 | Completed

• 1 other identifier: 12-214-SDR
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Inflammatory Bowel Diseases; Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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).

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

Study Arms (1)

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

Interventions

orthogonal polarization spectral (OPS) imaging DEVICE

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

Elective colorectal surgeries

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients older than 18 yo undergoing elective laparoscopic colorectal surgery with an Enhanced Recovery Program (ERP) at the Montreal General Hospital

You may not qualify if:

• Any patient who refuses enrolment

Sponsors & Collaborators

• Gabriele Baldini, MD, MSc, Assistant Professor: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (17)

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

  PMID: 19617822 BACKGROUND

• 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.

  PMID: 18695704 BACKGROUND

• Hasibeder W. Gastrointestinal microcirculation: still a mystery? Br J Anaesth. 2010 Oct;105(4):393-6. doi: 10.1093/bja/aeq236. No abstract available.

  PMID: 20837720 BACKGROUND

• 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.

  PMID: 22713365 BACKGROUND

• 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.

  PMID: 18936911 BACKGROUND

• Cassina T, Santambrogio L. Microcirculation after cardiopulmonary bypass: a glance at the mesenteric mucosa. Minerva Anestesiol. 2012 Mar;78(3):288-90. No abstract available.

  PMID: 22357370 BACKGROUND

• 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.

  PMID: 19853081 BACKGROUND

• 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.

  PMID: 21519309 BACKGROUND

• 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.

  PMID: 19639371 BACKGROUND

• 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. doi: 10.1097/01.TP.0000056634.18191.1A.

  PMID: 12660497 BACKGROUND

• Rauchfuss F, Scheuerlein H, Ludewig S, Uberruck 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.

  PMID: 20666991 BACKGROUND

• De Backer D, Hollenberg S, Boerma C, Goedhart P, Buchele 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. doi: 10.1186/cc6118.

  PMID: 17845716 BACKGROUND

• 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. doi: 10.1007/BF02237248.

  PMID: 10813128 BACKGROUND

• Trzeciak S, Rivers EP. Clinical manifestations of disordered microcirculatory perfusion in severe sepsis. Crit Care. 2005;9 Suppl 4(Suppl 4):S20-6. doi: 10.1186/cc3744. Epub 2005 Aug 25.

  PMID: 16168070 BACKGROUND

• 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. doi: 10.1136/bmj.323.7316.773.

  PMID: 11588077 BACKGROUND

• 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. doi: 10.1097/00000658-199208000-00008.

  PMID: 1386982 BACKGROUND

• 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.

  PMID: 19837807 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammatory Bowel Diseases

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gabriele Baldini, MD, MSc

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assitant Professor

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: April 10, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

CA (1)