Neutrophil-to-lymphocyte Ratio vs C-reactive Protein as Early Predictors of Anastomotic Leakage After Colorectal Surgery

NCT04673110 | Completed

• 1 other identifier: 0818040
• Study Type: observational
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Colorectal surgery (CRS) is associated with high morbidity rates, being anastomotic leakage (AL) one of the most serious complications with an incidence as high as 15%, accounting for up to a third of mortality in these procedures. The identification of pre-clinical markers may allow an early diagnosis and a timely intervention. Objective: To compare the performance of neutrophil-to-lymphocyte ratio (NLR) vs C-reactive protein (CRP) as early predictors of AL in CRS. Methodology: A retrospectively analyzed consecutive patients who underwent a colorectal surgery with anastomosis from June 2015 to April 2019. Receiver-operating characteristic (ROC) curves were used to find the cutoff points with the best diagnostic performance of AL.

Conditions

Anastomotic Leak

Keywords

neutrophil-to-lymphocyte ratio; C-reactive protein; preclinical marker; colorectal surgery; complications

Outcome Measures

Primary Outcomes (5)

• Demographic variables

  sex and age

  2015-2019

• inpatient stay

  days

  2015-2019

• value of C-reactive protein

  normal value under 5 mg/dL

  2015-2019

• value of Neutrophil to Lymphocyte Ratio

  It can be obtained from the blood count (the absolute neutrophil count divided by the absolute lymphocyte count)

  2015-2019

• the timing of the operation

  elective or emergency

  2015-2019

Study Arms (2)

Anastomotic leakage group

9 patients developed anastomotic leakage (8%) in a median of 8 days (range: 5-9) median CRP level postoperative day 4:164mg/dL

Diagnostic Test: Neutrophil to Lymphocyte Ratio and C-reactive protein

no Anastomotic leakage group

117 patients (92%) median CRP level postoperative day 4: 64mg/dL

Diagnostic Test: Neutrophil to Lymphocyte Ratio and C-reactive protein

Interventions

Neutrophil to Lymphocyte Ratio and C-reactive protein DIAGNOSTIC_TEST

Zahorec et al. identified the neutrophil-lymphocyte ratio (NLR) as an inflammation marker in critical patients, defining as the absolute neutrophil count divided by the absolute lymphocyte count

Anastomotic leakage group; no Anastomotic leakage group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

116 patients

You may qualify if:

• Patients older than 18 years.
• All colorectal resections (open or laparoscopic).
• Confection of a diverting loop ostomy.
• Timing of surgery (urgent or scheduled).

You may not qualify if:

• Patients under 18 years of age.
• Patients with hematological diseases.
• Patients with extra abdominal infections.
• Patients with oncological diseases
• Patients whit definitive colostomy (i.e. Miles operation),
• Patients did not have a primary anastomosis (e.g. Hartmann's operation).

Sponsors & Collaborators

• Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba: lead

Related Publications (7)

• Paun BC, Cassie S, MacLean AR, Dixon E, Buie WD. Postoperative complications following surgery for rectal cancer. Ann Surg. 2010 May;251(5):807-18. doi: 10.1097/SLA.0b013e3181dae4ed.

  PMID: 20395841 BACKGROUND

• Alves A, Panis Y, Mathieu P, Mantion G, Kwiatkowski F, Slim K; Association Francaise de Chirurgie. Postoperative mortality and morbidity in French patients undergoing colorectal surgery: results of a prospective multicenter study. Arch Surg. 2005 Mar;140(3):278-83, discussion 284. doi: 10.1001/archsurg.140.3.278.

  PMID: 15781793 BACKGROUND

• Choy PY, Bissett IP, Docherty JG, Parry BR, Merrie A, Fitzgerald A. Stapled versus handsewn methods for ileocolic anastomoses. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD004320. doi: 10.1002/14651858.CD004320.pub3.

  PMID: 21901690 BACKGROUND

• Kingham TP, Pachter HL. Colonic anastomotic leak: risk factors, diagnosis, and treatment. J Am Coll Surg. 2009 Feb;208(2):269-78. doi: 10.1016/j.jamcollsurg.2008.10.015. Epub 2008 Dec 4. No abstract available.

  PMID: 19228539 BACKGROUND

• Ortega-Deballon P, Radais F, Facy O, d'Athis P, Masson D, Charles PE, Cheynel N, Favre JP, Rat P. C-reactive protein is an early predictor of septic complications after elective colorectal surgery. World J Surg. 2010 Apr;34(4):808-14. doi: 10.1007/s00268-009-0367-x.

  PMID: 20049435 BACKGROUND

• Trencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd.

  PMID: 22968068 BACKGROUND

• Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.

  PMID: 23728278 BACKGROUND

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: December 17, 2020
• Study Start: June 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: February 1, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share