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Anastomotic LeakNCT04673110

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

An observational study of Anastomotic Leak, run by Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 90 years
Conditions the study is for
Anastomotic Leak
What is being tested?
Neutrophil to Lymphocyte Ratio and C-reactive protein
How many people
116 participants
Where
No sites listed yet
Study dates
1 Jun 2015to 1 Feb 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 19 to 90 years
  • All sexes
  • Adult, Older adult

Study population: 116 patients

Who may be able to join

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

Who cannot join

  • 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).

About this study

Official title: Neutrophil-to-lymphocyte Ratio vs C-reactive Protein as Early Predictors of Anastomotic Leakage After Colorectal Surgery: A Retrospective Cohort Study

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.

Read the detailed description

Introduction Colorectal surgery (CRS) has improved immensely over recent decades as a consequence of better presurgical preparation, antibiotic prophylaxis, surgical technique, and postoperative management. However, it is may still be associated with somehow high morbidity and mortality rates. Prospective multicenter studies have demonstrated that 30-day morbidity and mortality may go up to 35% and 9% respectively. The most frequent postoperative complications include surgical site infection, intraabdominal abscess, ileus, hemorrhage, and anastomotic leakage (AL). Of these, AL is considered the most serious, with an incidence that varies from 3% to 15% and is responsible for up to a third of mortality in these patients. It is worth noting that most of them become evident between postoperative days 5 and 7, and the highest rates occur in coloanal anastomosis (10 to 20%). Early detection of serious postoperative complications such as AL in patients who undergo CRS is crucial for effective decision-making that anticipates septic complications. Although few markers have been studied as predictors of postoperative complications, in an era of enhanced recovery after surgery (ERAS) or Fast Track Surgery in which patients are discharged rapidly, the identification and use of pre-clinical inflammatory biomarkers may become of utmost importance to allow early diagnosis of serious complications. C-reactive protein (CRP) is an acute-phase reactant of hepatic synthesis, which raises in most of the inflammatory processes in response to proinflammatory cytokines as interleukin (IL) 6, IL-1 beta, tumor necrosis factor-alpha, and interferon-gamma. It has been noted that high concentrations of CRP at the third and fourth postoperative day may be associated with the development of septic intra-abdominal complications such as AL after CRS. On the other hand, pre and postoperative neutrophil-to-lymphocyte ratio (NLR), a simple and costless marker of a subclinical inflammatory response, has recently been identified as a useful predictor of major complications after surgery. Moreover, it has been recently suggested that preoperative NLR might be better than CRP as a predictor of 30-day morbidity after major abdominal surgery. With regards to CRS, it has been recently suggested that an elevated preoperative NLR may be a risk factor for major surgical complications following colorectal resection, with a trend towards the occurrence of AL. Although NLR may be advantageous in the clinical setting given that it has shown a faster kinetic pattern than CRP in response to surgical trauma, whether postoperative NLR can early predict the occurrence of AL in after CRS remains unknown.

The aim of the present study was to determine the value of postoperative NLR as an early predictor of AL in patients who undergo CRS and compare its diagnostic performance with CRP.

Material and methods Study design and population: The current report represents a single-institution retrospective cohort analysis of a prospectively maintained database. Data for consecutive patients submitted to colorectal surgery from June 2015 to April 2019 at a General Surgery Service of a tertiary referral University Hospital was extracted. All colorectal resections were included in the study analysis regardless on the approach used (open or laparoscopic), the confection of a diverting loop ostomy or the timing of surgery (urgent or scheduled). From a total 152 patients, 36 were excluded due to incomplete medical records, hematological diseases, extra-abdominal infections, definitive colostomy (i.e. Miles operation), or those who did not have a primary anastomosis (e.g. Hartmann's operation). Informed consent was obtained for all patients before surgery.

Surgical Technique and follow-up: All the procedures were performed by staff surgeons, including a colorectal surgery specialist. Regarding the techniques used for the anastomosis, all colorectal or ileorectal anastomosis were performed used staplers and ileocolic anastomosis were either performed using staplers or hand-sewn technique. After discharge, all patients were controlled through clinical evaluation and routine laboratory tests in an outpatient office at 2 weeks and 1 month after surgery, and every 4 months thereafter in oncological patients. Data on each patient was recorded prospectively from the date of index operation up to a minimum of 12 months after surgery or until death whichever occurred first.

Study variables and definitions: Patients demographics, indication for surgery, timing of the operation (elective or emergency), surgical risk according to ASA (American Society of Anesthesiologists), resection type, surgical approach (open or laparoscopic), need of diverting ileostomy, hospital stay and postoperative complications were analyzed. The Comprehensive Complication Index (CCI) was used to grade postoperative morbidity, which integrates in a single formula all the complications suffered by the patient according to the Clavien-Dindo score, summarizing postoperative (POP) morbidity in a grading score that goes from 1 to 100. Serum concentration of CRP and NLR during the first 5 postoperative days was recorded. All patients had complete cytology every day up to day 5 in order to calculate the ratio between the absolute value of neutrophils and the absolute value of lymphocytes. A CRP level below 5 mg/dL was considered normal. We analyzed the relationship between the variables and the development of AL. According to laboratory findings and clinical judgement, additional imaging studies were employed to rule out AL. AL was defined as suture line disruption with intestinal content leakage or abscess formation, associated to fever or abdominal pain, and confirmed by a CT-scan or re-operation up to 3 months after CRS.

Statistical Analysis: Continuous variables are expressed as means and standard deviation (SD) for symmetrically distributed, and median (range) for non-symmetrically distributed data. Categorical variables were expressed as frequencies (percentages). The Mann-Whitney test was used for comparison of continuous variables and Chi-squared test or Fisher's exact test was used for comparisons of categorical variables between patients with and without AL. The differences between variables were considered significant at a value of p≤0.05. Receiver operating characteristic (ROC) curves were used to evaluate the diagnostic accuracy of CRP and NLR as predictors of AL, determining sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV). The diagnostic accuracy of the plasmatic markers studied was based on the area under the ROC curve (AUC). We used the Youden Index to find the cutoff point with the best diagnostic performance of CRP and NLR on the first five postoperative days. SPSS versión 24 and GraphPad version 7 were used for statistical analysis.

Being tested
Neutrophil to Lymphocyte Ratio and C-reactive protein
Keywords
neutrophil-to-lymphocyte ratio, C-reactive protein, preclinical marker, colorectal surgery, complications
Medical subject headings
Anastomotic Leak

What participants receive

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

  • Neutrophil to Lymphocyte Ratio and C-reactive proteinDiagnostic 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

Study groups in NCT04673110
Study groupRoleWhat they receive
Anastomotic leakage group9 patients developed anastomotic leakage (8%) in a median of 8 days (range: 5-9) median CRP level postoperative day 4:164mg/dL
Receives: Diagnostic Test: Neutrophil to Lymphocyte Ratio and C-reactive protein
no Anastomotic leakage group117 patients (92%) median CRP level postoperative day 4: 64mg/dL
Receives: Diagnostic Test: Neutrophil to Lymphocyte Ratio and C-reactive protein

What is being measured

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

  1. Demographic variables

    sex and age

    Measured: 2015-2019

  2. inpatient stay

    days

    Measured: 2015-2019

  3. value of C-reactive protein

    normal value under 5 mg/dL

    Measured: 2015-2019

  4. value of Neutrophil to Lymphocyte Ratio

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

    Measured: 2015-2019

  5. the timing of the operation

    elective or emergency

    Measured: 2015-2019

Timeline

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

  1. First posted17 Dec 2020
  2. Study start1 Jun 2015
  3. Primary completion1 Apr 2019
  4. Study completion1 Feb 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
Cohort
Time perspective
Retrospective
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673110
Sponsor's protocol ID
0818040
Status last verified
Dec 2020
First submitted
12 Dec 2020
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to the sensitive nature of the study, patients were assured that the raw data would remain confidential and would not be shared.

Publications

  • 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.

    PubMed 20395841
  • 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.

    PubMed 15781793
  • 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.

    PubMed 21901690
  • 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.

    PubMed 19228539
  • 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.

    PubMed 20049435
  • 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.

    PubMed 22968068
  • 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.

    PubMed 23728278

Questions about this trial

What is this clinical trial studying?

An observational study of Anastomotic Leak, run by Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba.

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 6 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Demographic variables (time frame: 2015-2019). The study lists 5 primary outcomes in all. 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 NCT04673110, which also lists 7 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 17 Dec 2020.

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