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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04846283
Acronym
ALbiomarkers
Enrollment
207
Registered
2021-04-15
Start date
2018-06-01
Completion date
2020-04-01
Last updated
2021-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leakage

Keywords

Anastomotic leakage, Colorectal surgery, Biomarkers

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.

Interventions

PROCEDUREElective 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

Sponsors

University of Palermo
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

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

Other

MeasureTime frameDescription
Measurement of drainage fluid pHPostoperative day 3Drainage fluid pH measurements were recorded on postoperative day 3 before drain removal.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026