AzTrials
AzTrials

Anastomotic LeakageALbiomarkersNCT04846283

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

An observational study of Anastomotic Leakage, run by University of Palermo at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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%. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Anastomotic Leakage
What is being tested?
Elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure
Type of treatment
Surgery or procedure
How many people
207 participants
Where
1 siteItaly
Study dates
1 Jun 2018to 1 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients undergoing elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure

Who may be able to join

  • 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.

Who cannot join

  • patients aged < 16 y undergoing colorectal surgery;
  • patients undergoing Hartman's procedure

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Palermo, Italy - Sicily, 90127

Other trials in Italy

About this study

Official title: 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.

Being tested
Elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure
Keywords
Anastomotic leakage, Colorectal surgery, Biomarkers
Medical subject headings
Anastomotic Leak

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT04846283
Study groupRoleWhat they receive
Biomarker-groupWe 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.
Receives: Procedure: Elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of drainage fluid CRP and LDH on postoperative day 3

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

    Measured: Postoperative day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2021
  2. Study start1 Jun 2018
  3. Primary completion1 Apr 2020
  4. Study completion1 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04846283
Sponsor's protocol ID
ANASTOMOTICLEAKAGE 01_2021
Acronym
ALbiomarkers
Status last verified
Apr 2021
First submitted
9 Apr 2021
Last updated
15 Apr 2021
Results posted
No
Individual data sharing
Undecided

Publications

  • Smith SR, Pockney P, Holmes R, Doig F, Attia J, Holliday E, Carroll R, Draganic B. Biomarkers and anastomotic leakage in colorectal surgery: C-reactive protein trajectory is the gold standard. ANZ J Surg. 2018 May;88(5):440-444. doi: 10.1111/ans.13937. Epub 2017 Mar 17.

    PubMed 28304142

  • Molinari E, Giuliani T, Andrianello S, Talamini A, Tollini F, Tedesco P, Pirani P, Panzeri F, Sandrini R, Remo A, Laterza E. Drain fluid's pH predicts anastomotic leak in colorectal surgery: results of a prospective analysis of 173 patients. Minerva Chir. 2020 Feb;75(1):30-36. doi: 10.23736/S0026-4733.19.08018-0. Epub 2019 Sep 30.

    PubMed 31580043

  • Straatman J, Cuesta MA, Tuynman JB, Veenhof AAFA, Bemelman WA, van der Peet DL. C-reactive protein in predicting major postoperative complications are there differences in open and minimally invasive colorectal surgery? Substudy from a randomized clinical trial. Surg Endosc. 2018 Jun;32(6):2877-2885. doi: 10.1007/s00464-017-5996-9. Epub 2017 Dec 27.

    PubMed 29282574

  • Pedrazzani C, Moro M, Mantovani G, Lazzarini E, Conci S, Ruzzenente A, Lippi G, Guglielmi A. C-reactive protein as early predictor of complications after minimally invasive colorectal resection. J Surg Res. 2017 Apr;210:261-268. doi: 10.1016/j.jss.2016.11.047. Epub 2016 Dec 5.

    PubMed 28457337

  • Cabellos Olivares M, Labalde Martinez M, Torralba M, Rodriguez Fraile JR, Atance Martinez JC. C-reactive protein as a marker of the surgical stress reduction within an ERAS protocol (Enhanced Recovery After Surgery) in colorectal surgery: A prospective cohort study. J Surg Oncol. 2018 Mar;117(4):717-724. doi: 10.1002/jso.24909. Epub 2018 Jan 22.

    PubMed 29355975

  • Wright EC, Connolly P, Vella M, Moug S. Peritoneal fluid biomarkers in the detection of colorectal anastomotic leaks: a systematic review. Int J Colorectal Dis. 2017 Jul;32(7):935-945. doi: 10.1007/s00384-017-2799-3. Epub 2017 Apr 12.

    PubMed 28401350

  • Walker PA, Kunjuraman B, Bartolo DCC. Neutrophil-to-lymphocyte ratio predicts anastomotic dehiscence. ANZ J Surg. 2018 Jan 27. doi: 10.1111/ans.14369. Online ahead of print.

    PubMed 29377500

  • Reynolds IS, Boland MR, Reilly F, Deasy A, Majeed MH, Deasy J, Burke JP, McNamara DA. C-reactive protein as a predictor of anastomotic leak in the first week after anterior resection for rectal cancer. Colorectal Dis. 2017 Sep;19(9):812-818. doi: 10.1111/codi.13649.

    PubMed 28273409

  • Agnello L, Buscemi S, Di Buono G, Vidali M, Lo Sasso B, Agrusa A, Ciaccio M. Drainage fluid LDH and neutrophil to lymphocyte ratio as biomarkers for early detecting anastomotic leakage in patients undergoing colorectal surgery. Clin Chem Lab Med. 2023 Nov 22;62(5):967-978. doi: 10.1515/cclm-2023-1164. Print 2024 Apr 25.

    PubMed 37988156

Questions about this trial

What is this clinical trial studying?

An observational study of Anastomotic Leakage, run by University of Palermo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of drainage fluid CRP and LDH on postoperative day 3 (time frame: Postoperative day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04846283, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in