Clinical trial NCT04846283: Drainage Fluid Biomarkers and Anastomotic Leakage in Colorectal Surgery. A Monocentric Prospective Observational Study
Official title: Drainage Fluid Biomarkers And Anastomotic Leakage In Colorectal Surgery. A Monocentric Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leakage
Keywords: Anastomotic leakage
Colorectal surgery
Biomarkers
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 207
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of drainage fluid CRP and LDH on postoperative day 3
timeFrame: Postoperative day 3
Secondary outcomes:
Other outcomes:
measure: Measurement of drainage fluid pH
timeFrame: Postoperative day 3
Locations:
city: Palermo
country: Italy
facility: A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo
state: Italy - Sicily
Study officials:
affiliation: University of Palermo - Italy
name: Antonino Agrusa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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