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

Completed

• Conditions: Anastomotic Leakage
• Interventions: Procedure: Elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure

• Registration Number: NCT04846283
• Lead Sponsor: University of Palermo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-14
• Last Update Submitted: 2021-04-14
• Study First Posted: 2021-04-15
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biomarker-group	Elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo; 🇮🇹 Palermo, Italy - Sicily, Italy