Drainage Fluid Biomarkers and Anastomotic Leakage in Colorectal Surgery. A Monocentric Prospective Observational Study

Study Overview
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Brief Summary
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Anastomotic leakage (AL) is one of the most feared intra-abdominal septic complications (IASC) after colorectal surgery. It is defined as the leak of intestinal content due to an anastomotic dehiscence. Incidence ranges from 2% to 20%. AL is usually associated to systemic inflammatory response, even if in some cases the presentation may be subclinical. Therefore, AL is suspected in patients with a strong inflammatory response and can be confirmed by imaging with contrast enhanced computed tomography (CT) scan or water-soluble contrast studies. Nevertheless, imaging has varying sensitivity and specificity and is usually performed once the patient has a clinical evidence, thus potentially delaying the correct timing for surgery. Despite several studies about this topic and the plenty of known risk factors as mentioned above, AL is still not easy to predict. Different tools other than imaging have been studied in order to make diagnosis of AL at an early stage, as the measurement of some biomarkers of inflammation in serum and in drainage fluid. Biomarkers as white cell blood count (WBC), C-reactive protein (CRP), cytokines (e.g. TNFa, IL-6, IL-1b), markers of ischemia (e.g. lactate) and procalcitonin (PCT) have been used for an early detection of AL and other intra-abdominal septic complications. The primary aim of our study was to assess the role of drainage fluid CRP and lactate-dehydrogenase (LDH) in the early detection of anastomotic leakage.

Official Title
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Drainage Fluid Biomarkers And Anastomotic Leakage In Colorectal Surgery. A Monocentric Prospective Observational Study

Conditions
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Anastomotic Leakage

Intervention / Treatment
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* Procedure: Elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged >16 y undergoing elective or emergency colorectal surgery for cancer patients aged >16 y undergoing elective or emergency colorectal surgery for diverticular disease patients aged >16 y undergoing elective or emergency colorectal surgery for inflammatory bowel-disease patients aged >16 y undergoing elective or emergency colorectal surgery for reversal of Hartmann's procedure. Exclusion Criteria: patients aged < 16 y undergoing colorectal surgery; patients undergoing Hartman's procedure

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biomarker-group<br>We considered for the study all patients aged >16 y undergoing elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure. Both patients undergoing open and minimally invasive surgery were considered eligible. | Procedure: Elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure<br>* We considered all the procedures that required an intestinal anastomosis in colo-rectal surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of drainage fluid CRP and LDH on postoperative day 3 | Our primary endpoint was to assess the role of drainage fluid CRP and LDH on postoperative day 3. | Postoperative day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anastomotic leakage, Colorectal surgery, Biomarkers