Skip to main content
Clinical Trials/NCT04846283
NCT04846283
Completed
Not Applicable

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

University of Palermo1 site in 1 country207 target enrollmentStarted: June 1, 2018Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
207
Locations
1
Primary Endpoint
Measurement of drainage fluid CRP and LDH on postoperative day 3

Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Measurement of drainage fluid CRP and LDH on postoperative day 3

Time Frame: Postoperative day 3

Our primary endpoint was to assess the role of drainage fluid CRP and LDH on postoperative day 3.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Antonino Agrusa

Associate professor

University of Palermo

Study Sites (1)

Loading locations...

Similar Trials