Sublingual Microcirculation and Postoperative Ileus

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828047
• Other study ID #: 12-214-SDR
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: March 16, 2015
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Gastrointestinal Dysfunction
• Inflammatory Bowel Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Gabriele Baldini, MD, MSc, Assistant Professor

Country where clinical trial is conducted

Canada, 

References & Publications (17)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No