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

NCT04846283 | Completed

• 1 other identifier: ANASTOMOTICLEAKAGE 01_2021
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Anastomotic Leakage

Keywords

Anastomotic leakage; Colorectal surgery; Biomarkers

Outcome Measures

Primary Outcomes (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.

  Postoperative day 3

Other Outcomes (1)

• Measurement of drainage fluid pH

  Postoperative day 3

Study Arms (1)

Biomarker-group

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.

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

Interventions

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

Biomarker-group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

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

Palermo, Italy - Sicily, 90127, Italy

Location

Related Publications (9)

• 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.

  PMID: 28304142 BACKGROUND

• 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.

  PMID: 31580043 BACKGROUND

• 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.

  PMID: 29282574 BACKGROUND

• 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.

  PMID: 28457337 BACKGROUND

• 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.

  PMID: 29355975 BACKGROUND

• 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.

  PMID: 28401350 BACKGROUND

• 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.

  PMID: 29377500 BACKGROUND

• 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.

  PMID: 28273409 BACKGROUND

• 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.

  PMID: 37988156 DERIVED

MeSH Terms

Conditions

Anastomotic Leak

Interventions

Elective Surgical Procedures

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Antonino Agrusa, Professor

  University of Palermo - Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 15, 2021
• Study Start: June 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

IT (1)