Drainage Fluid Biomarkers and Anastomotic Leakage in Colorectal Surgery. A Monocentric Prospective Observational Study
NCT ID: NCT04846283
Last Updated: 2021-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
207 participants
OBSERVATIONAL
2018-06-01
2020-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Elective 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
Interventions
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Elective 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
Eligibility Criteria
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Inclusion Criteria
* 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 undergoing Hartman's procedure
16 Years
ALL
No
Sponsors
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University of Palermo
OTHER
Responsible Party
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Prof. Antonino Agrusa
Associate professor
Principal Investigators
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Antonino Agrusa, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Palermo - Italy
Locations
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A.U.O. Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo
Palermo, Italy - Sicily, Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ANASTOMOTICLEAKAGE 01_2021
Identifier Type: -
Identifier Source: org_study_id
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