Skip to main content
OpenTrials
Completed

NCT Number: NCT04846283

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo

Palermo, Italy - Sicily, 90127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure

Procedure

We considered all the procedures that required an intestinal anastomosis in colo-rectal surgery

Primary outcomes

  1. 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.

Other outcomes

  1. Measurement of drainage fluid pH

    Time frame: Postoperative day 3

    Drainage fluid pH measurements were recorded on postoperative day 3 before drain removal.

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Acronym: ALbiomarkers

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2021
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.