An observational study in Anastomotic Leakage, sponsored by University of Palermo. Completed at 1 site in Italy. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by University of Palermo · Observational
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.
209 studies on the registry are indexed under Anastomotic Leak; 60 are open to participants now.
This study's enrollment of 207 is close to the median of 200 across 108 observational studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →University of Palermo is the lead sponsor of 142 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure
Exclusion Criteria:
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
We considered all the procedures that required an intestinal anastomosis in colo-rectal surgery
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.
Time frame: Postoperative day 3
Measurement of drainage fluid pH
Drainage fluid pH measurements were recorded on postoperative day 3 before drain removal.
Time frame: Postoperative day 3
Plan to share: Undecided
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of Palermo