Anastomotic leakage is one of the most severe complications of surgical operations involving resections of the gastro-intestinal (GI) tract. Early diagnosis may play a pivotal role in the reduction of morbidity and mortality in the post-operative course. In the last few years, in addition to the most used biomarkers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT), presepsin dosage has been described as a relevant and early inflammatory biomarker.
The aim of this study is to monitor and to identify the possible predictive role of presepsin in the early diagnosis of intestinal anastomotic leakage. Indeed, presepsin (sCD14-ST) is a soluble fragment of the multifunctional glycoprotein CD14, localized mainly on the membrane surface of monocytes/macrophages. It is one of the triggers of the inflammatory cascade also involved in the innate immunity, and early elevated in those patients diagnosed with sepsis. Interestingly, a recent study of M. Cikot assumed that presepsin may contribute significantly to the early detection of anastomotic leakage.
This one would be an Italian, prospective, monocentric study. Data collection and analysis will be carried out by the Department of General Surgery AOU Sant'Andrea of Rome.
All patients over 18 years of age undergoing emergency surgery for major abdominal surgery which resulted in bowel resection with anastomosis will be enrolled, after obtaining informed consent and approval of the Ethics Committee of the AOU of Sant'Andrea, in the current study.
In the postoperative course, in addition to the complete monitoring of the patient's clinical condition (vital signs, routine blood tests, eventual radiological imaging), blood samples will be taken to search for inflammatory values (White Blood Cell count, PCR , PCT) and for the assay of the soluble subtype of the presepsin molecule (sCD4-ST) on the 1st, 3rd and 5th postoperative day.
The dosage of presepsin in blood could significantly contribute to the early identification of patients at high risk of anastomotic leakage, as well as to the reduction of associated comorbidities and mortality. The definition of a range of normal values and a range of pre-pathological and pathological values, could guide the management of the patient in the post-operative period, representing a substantial modification of the clinical practice.
Study feasibility:
The General Surgery and Emergency Surgery Units ensure that all patients who will arrive in the ED and who will undergo bowel resection surgery with anastomosis will be referred to this clinical study in order to guarantee a satisfactory and statistically significant patient population sample.
Despite numerous clinical studies regarding intestinal anastomotic leakage as one of the most severe surgical complications, there is still no consensus on the management and early diagnosis of anastomotic dehiscence. To the best of our knowledge, the role of presepsin in major abdominal surgery has not yet been studied and it may have a great impact on management of these patients.