Acute DiverticulitisNCT04663490
Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis
An observational study of Acute Diverticulitis, run by Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba at 1 site in Argentina.
Trial summary
Introduction: Various biomarkers have been studied to predict the severity of acute diverticulitis (AD), such as the leukocyte count and CRP, which are useful but lack sufficient sensitivity. The neutrophil-lymphocyte ratio (NLR) has been identified as a new inflammatory biomarker in several abdominal pathologies. Read more about this study
- Who is it for?
- Ages 18 to 92 years
- Conditions the study is for
- Acute Diverticulitis
- What is being tested?
- Neutrophil to Lymphocyte Ratio
- How many people
- 325 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jan 2013to 1 Jan 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 18 to 92 years
- All sexes
- Adult, Older adult
Study population: 325 patients
Who may be able to join
- Patients older than 18 years.
- Patients with a diagnosis of acute diverticulitis confirmed by computed tomography.
Who cannot join
- Patients under 18 years of age.
- Patients with hematological diseases.
- Patients with extra abdominal infections.
- Patients with oncological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis: A Retrospective Cohort Study
Introduction: Various biomarkers have been studied to predict the severity of acute diverticulitis (AD), such as the leukocyte count and CRP, which are useful but lack sufficient sensitivity. The neutrophil-lymphocyte ratio (NLR) has been identified as a new inflammatory biomarker in several abdominal pathologies. However, few studies determine its association with the severity of AD. The objective of the present study was to determine the utility and diagnostic precision of NLR in complicated acute diverticulitis (cAD).
Material and methods: Descriptive, retrospective and analytical study. Patients older than 18 years with a diagnosis of AD were included, from 2013 - 2018. Demographic variables, days of hospitalization, leukocyte count, neutrophils, lymphocytes, ESR, CRP, and NLR were analyzed. The sensitivity and specificity for the diagnosis of cAD were determined using ROC curves.
Read the detailed description
Introduction Acute diverticulitis (AD) is present in 10-25% of patients with diverticular disease, being most common in sigmoid colon, with around 200.000 hospitalizations yearly . As much as one fifth of patients are younger than 50 at the moment of diagnosis and around 5% under the age of 40 .
Confirming the diagnosis requires the utilization of imaging studies, therefore, American Society of Colon and Rectal Surgeons (ASCRS) established that computed tomography (CT) is the standard method for the diagnosis of AD, with a sensitivity of 98% and a specificity of 99%. The tomographic findings vary according the severity of diverticular disease, which is categorized through a modified Hinchey classification system. Approximately 10-15% of AD patients may develop complications that imply the onset of abscesses, fistulas, stenosis, obstruction and/or perforation.
Recently, interest has been raised in the role of biomarkers in diverticular disease as non-invasive, reliable, inexpensive tools that may help in the early diagnosis of complicated AD, such as C-reactive protein (CRP), useful marker in the prediction of the level of inflammation and severity of AD.
In 2001 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. Over the last decade, NLR effectiveness has been recognized in various pathologies, both benign and malignant; finding that the levels of neutrophils rise as a part of the inflammatory cascade, whereas lymphocytes diminish during sepsis, making a novel subclinical biomarker with a prognostic value in oncological, cardiovascular and infectious diseases, among others. The NLR may be obtained from the blood count data, which represents a lower cost regarding other known biomarkers. It was also demonstrated that high values of NLR are associated with severe abdominal infections and worse outcomes, reason why it started to be applied as a predictor to evaluate results in surgical patients.
Currently, the debate on usefulness of NLR as a predictor of complications in AD remains open, specially, the relation to the severity of the disease, the clinical impact and the necessity of minimally invasive or emergency surgical procedures.
On the other hand, its diagnostic efficacy has not been studied even in our field. Up until now, there are only four studies published in Ireland, Israel, and South Korea. The purpose of the study was to determine the usefulness and diagnostic accuracy of NLR in complicated acute diverticulitis (cAD).
Material and methods Study population A descriptive, retrospective cohort and analytical study was undertaken. Medical histories and an electronic database from General Surgery Service were reviewed. All the patients over the age of 18 with AD diagnosis through CT were included, since January 2013 until January 2018 in a University Hospital of Cordoba, Argentina, with third level reference.
Patients were excluded if they had chronic diseases, susceptible to modify the immune inflammatory response, extra-abdominal infections, immunosuppression and neoplasias, and those who supplied incomplete data in their electronic clinical histories.
Study of variables Demographic variables (sex and age), days of inpatient stay, level of severity in diverticular process (objectified by CT) were analyzed. It was recorded the value of serum leukocyte, neutrophil, and lymphocyte concentration, Erythrocyte Sedimentation Rate (ESR), CRP and NLR at the moment of consultation on call.
Variable definition NLR: It can be obtained from the blood count (the absolute neutrophil count divided by the absolute lymphocyte count) CRP: normal value under 5 mg/l. Statistical analysis The categorical variables were expressed as frequency (percentage), the continuous variables as mean value (standard deviation, SD) or median (range) according to the distribution of data; Mann Whitney test was used to compare the continuous variables, Chi-square and Fisher's tests were used to compare categorical variables among patients with simple acute diverticulitis (sAD) and cAD. A value of p<0.05 was considered as statistically significant.
ROC (Receiver Operating Characteristic) curves were used as diagnostic tests to evaluate the diagnostic accuracy of NLR as predictor of complicated AD, determining sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV). Youden index was used to find the cut-off point with the best diagnostic yield for NLR in cAD. SPSS 26 software and GraphPad 7 software were used for statistical analysis.
- Conditions
- Acute Diverticulitis
- Being tested
- Neutrophil to Lymphocyte Ratio
- Keywords
- neutrophil-to-lymphocyte ratio, C-reactive protein, biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutrophil to Lymphocyte RatioDiagnostic 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 group | Role | What they receive |
|---|---|---|
| simple acute diverticulitis | Ninety-one percent (n=295) were categorized as simple acute diverticulitis Receives: Diagnostic Test: Neutrophil to Lymphocyte Ratio | |
| complicated acute diverticulitis | 9% (n=30) presented were categorized as complicated acute diverticulitis Receives: Diagnostic Test: Neutrophil to Lymphocyte Ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic variables
sex and age
Measured: 2013-2018
inpatient stay
days
Measured: 2013-2018
level of severity in diverticular process
confirmed by computed tomography
Measured: 2013-2018
value of C-reactive protein
normal value under 5 mg/l
Measured: 2013-2018
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: 2013-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Jan 2013
- Primary completion1 Jan 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Acute DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Palacios Huatuco, Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663490
- Sponsor's protocol ID
- 0717040
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2020
- Last updated
- 11 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
Weizman AV, Nguyen GC. Diverticular disease: epidemiology and management. Can J Gastroenterol. 2011 Jul;25(7):385-9. doi: 10.1155/2011/795241.
PubMed 21876861Feingold D, Steele SR, Lee S, Kaiser A, Boushey R, Buie WD, Rafferty JF. Practice parameters for the treatment of sigmoid diverticulitis. Dis Colon Rectum. 2014 Mar;57(3):284-94. doi: 10.1097/DCR.0000000000000075. No abstract available.
PubMed 24509449Barat M, Dohan A, Pautrat K, Boudiaf M, Dautry R, Guerrache Y, Pocard M, Hoeffel C, Eveno C, Soyer P. Acute colonic diverticulitis: an update on clinical classification and management with MDCT correlation. Abdom Radiol (NY). 2016 Sep;41(9):1842-50. doi: 10.1007/s00261-016-0764-1.
PubMed 27138434Wasvary H, Turfah F, Kadro O, Beauregard W. Same hospitalization resection for acute diverticulitis. Am Surg. 1999 Jul;65(7):632-5; discussion 636.
PubMed 10399971Bates DDB, Fernandez MB, Ponchiardi C, von Plato M, Teich JP, Narsule C, Anderson SW, Gupta A, LeBedis CA. Surgical management in acute diverticulitis and its association with multi-detector CT, modified Hinchey classification, and clinical parameters. Abdom Radiol (NY). 2018 Aug;43(8):2060-2065. doi: 10.1007/s00261-017-1422-y.
PubMed 29204676Kaser SA, Fankhauser G, Glauser PM, Toia D, Maurer CA. Diagnostic value of inflammation markers in predicting perforation in acute sigmoid diverticulitis. World J Surg. 2010 Nov;34(11):2717-22. doi: 10.1007/s00268-010-0726-7.
PubMed 20645093Zahorec R. Ratio of neutrophil to lymphocyte counts--rapid and simple parameter of systemic inflammation and stress in critically ill. Bratisl Lek Listy. 2001;102(1):5-14. English, Slovak.
PubMed 11723675Zahorec R. Neutrophil-to-lymphocyte ratio. Sixteen-year-long history since publication of our article in Bratislava Medical Journal. Bratisl Lek Listy. 2017;118(6):321-323. doi: 10.4149/BLL_2017_062. No abstract available.
PubMed 28664739Miyamoto R, Inagawa S, Sano N, Tadano S, Adachi S, Yamamoto M. The neutrophil-to-lymphocyte ratio (NLR) predicts short-term and long-term outcomes in gastric cancer patients. Eur J Surg Oncol. 2018 May;44(5):607-612. doi: 10.1016/j.ejso.2018.02.003. Epub 2018 Feb 13.
PubMed 29478743Reynolds IS, Heaney RM, Khan W, Khan IZ, Waldron R, Barry K. The Utility of Neutrophil to Lymphocyte Ratio as a Predictor of Intervention in Acute Diverticulitis. Dig Surg. 2017;34(3):227-232. doi: 10.1159/000450836. Epub 2016 Dec 10.
PubMed 27941316Hogan J, Sehgal R, Murphy D, O'Leary P, Coffey JC. Do Inflammatory Indices Play a Role in Distinguishing between Uncomplicated and Complicated Diverticulitis? Dig Surg. 2017;34(1):7-11. doi: 10.1159/000447250. Epub 2016 Jun 24.
PubMed 27336407Zager Y, Horesh N, Dan A, Aharoni M, Khalilieh S, Cordoba M, Nevler A, Gutman M, Rosin D. Associations of novel inflammatory markers with long-term outcomes and recurrence of diverticulitis. ANZ J Surg. 2020 Oct;90(10):2041-2045. doi: 10.1111/ans.16220. Epub 2020 Aug 28.
PubMed 32856387Mari A, Khoury T, Lubany A, Safadi M, Farraj M, Farah A, Kadah A, Sbeit W, Mahamid M. Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios Are Correlated with Complicated Diverticulitis and Hinchey Classification: A Simple Tool to Assess Disease Severity in the Emergency Department. Emerg Med Int. 2019 Aug 14;2019:6321060. doi: 10.1155/2019/6321060. eCollection 2019.
PubMed 31485352Kang HS, Cha YS, Park KH, Hwang SO. Delta neutrophil index as a promising prognostic marker of emergent surgical intervention for acute diverticulitis in the emergency department. PLoS One. 2017 Nov 1;12(11):e0187629. doi: 10.1371/journal.pone.0187629. eCollection 2017.
PubMed 29091955Agha RA, Borrelli MR, Vella-Baldacchino M, Thavayogan R, Orgill DP; STROCSS Group. The STROCSS statement: Strengthening the Reporting of Cohort Studies in Surgery. Int J Surg. 2017 Oct;46:198-202. doi: 10.1016/j.ijsu.2017.08.586. Epub 2017 Sep 7.
PubMed 28890409
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil to Lymphocyte Ratio as a Predictor of Complicated Acute Diverticulitis: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04663490
- Acronym / sponsor ID
- 0717040
- Conditions
- Acute Diverticulitis
- Keywords
- neutrophil-to-lymphocyte ratio, C-reactive protein, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Clinica Universitaria Reina Fabiola, Universidad Catolica de CordobaUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Various biomarkers have been studied to predict the severity of acute diverticulitis (AD), such as the leukocyte count and CRP, which are useful but lack sufficient sensitivity. The neutrophil-lymphocyte ratio (NLR) has been identified as a new inflammatory biomarker in several abdominal pathologies. However, few studies determine its association with the severity of AD. The objective of the present study was to determine the utility and diagnostic precision of NLR in complicated acute diverticulitis (cAD).
Material and methods: Descriptive, retrospective and analytical study. Patients older than 18 years with a diagnosis of AD were included, from 2013 - 2018. Demographic variables, days of hospitalization, leukocyte count, neutrophils, lymphocytes, ESR, CRP, and NLR were analyzed. The sensitivity and specificity for the diagnosis of cAD were determined using ROC curves.
Detailed description
Introduction Acute diverticulitis (AD) is present in 10-25% of patients with diverticular disease, being most common in sigmoid colon, with around 200.000 hospitalizations yearly . As much as one fifth of patients are younger than 50 at the moment of diagnosis and around 5% under the age of 40 .
Confirming the diagnosis requires the utilization of imaging studies, therefore, American Society of Colon and Rectal Surgeons (ASCRS) established that computed tomography (CT) is the standard method for the diagnosis of AD, with a sensitivity of 98% and a specificity of 99%. The tomographic findings vary according the severity of diverticular disease, which is categorized through a modified Hinchey classification system. Approximately 10-15% of AD patients may develop complications that imply the onset of abscesses, fistulas, stenosis, obstruction and/or perforation.
Recently, interest has been raised in the role of biomarkers in diverticular disease as non-invasive, reliable, inexpensive tools that may help in the early diagnosis of complicated AD, such as C-reactive protein (CRP), useful marker in the prediction of the level of inflammation and severity of AD.
In 2001 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. Over the last decade, NLR effectiveness has been recognized in various pathologies, both benign and malignant; finding that the levels of neutrophils rise as a part of the inflammatory cascade, whereas lymphocytes diminish during sepsis, making a novel subclinical biomarker with a prognostic value in oncological, cardiovascular and infectious diseases, among others. The NLR may be obtained from the blood count data, which represents a lower cost regarding other known biomarkers. It was also demonstrated that high values of NLR are associated with severe abdominal infections and worse outcomes, reason why it started to be applied as a predictor to evaluate results in surgical patients.
Currently, the debate on usefulness of NLR as a predictor of complications in AD remains open, specially, the relation to the severity of the disease, the clinical impact and the necessity of minimally invasive or emergency surgical procedures.
On the other hand, its diagnostic efficacy has not been studied even in our field. Up until now, there are only four studies published in Ireland, Israel, and South Korea. The purpose of the study was to determine the usefulness and diagnostic accuracy of NLR in complicated acute diverticulitis (cAD).
Material and methods Study population A descriptive, retrospective cohort and analytical study was undertaken. Medical histories and an electronic database from General Surgery Service were reviewed. All the patients over the age of 18 with AD diagnosis through CT were included, since January 2013 until January 2018 in a University Hospital of Cordoba, Argentina, with third level reference.
Patients were excluded if they had chronic diseases, susceptible to modify the immune inflammatory response, extra-abdominal infections, immunosuppression and neoplasias, and those who supplied incomplete data in their electronic clinical histories.
Study of variables Demographic variables (sex and age), days of inpatient stay, level of severity in diverticular process (objectified by CT) were analyzed. It was recorded the value of serum leukocyte, neutrophil, and lymphocyte concentration, Erythrocyte Sedimentation Rate (ESR), CRP and NLR at the moment of consultation on call.
Variable definition NLR: It can be obtained from the blood count (the absolute neutrophil count divided by the absolute lymphocyte count) CRP: normal value under 5 mg/l. Statistical analysis The categorical variables were expressed as frequency (percentage), the continuous variables as mean value (standard deviation, SD) or median (range) according to the distribution of data; Mann Whitney test was used to compare the continuous variables, Chi-square and Fisher's tests were used to compare categorical variables among patients with simple acute diverticulitis (sAD) and cAD. A value of p<0.05 was considered as statistically significant.
ROC (Receiver Operating Characteristic) curves were used as diagnostic tests to evaluate the diagnostic accuracy of NLR as predictor of complicated AD, determining sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV). Youden index was used to find the cut-off point with the best diagnostic yield for NLR in cAD. SPSS 26 software and GraphPad 7 software were used for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simple acute diverticulitis | – | Diagnostic Test: Neutrophil to Lymphocyte RatioNinety-one percent (n=295) were categorized as simple acute diverticulitis |
| complicated acute diverticulitis | – | Diagnostic Test: Neutrophil to Lymphocyte Ratio9% (n=30) presented were categorized as complicated acute diverticulitis |
Who may qualify
- Ages
- 18 to 92 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 325 patients
Key inclusion criteria (2 listed)
- Patients older than 18 years.
- Patients with a diagnosis of acute diverticulitis confirmed by computed tomography.
Key exclusion criteria (4 listed)
- Patients under 18 years of age.
- Patients with hematological diseases.
- Patients with extra abdominal infections.
- Patients with oncological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutrophil to Lymphocyte RatioZahorec 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 | Diagnostic test | complicated acute diverticulitis, simple acute diverticulitis |
Primary outcome
Demographic variables
Time frame: 2013-2018
sex and age
inpatient stay
Time frame: 2013-2018
days
level of severity in diverticular process
Time frame: 2013-2018
confirmed by computed tomography
value of C-reactive protein
Time frame: 2013-2018
normal value under 5 mg/l
value of Neutrophil to Lymphocyte Ratio
Time frame: 2013-2018
It can be obtained from the blood count (the absolute neutrophil count divided by the absolute lymphocyte count)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Background: PubMed 21876861Weizman AV, Nguyen GC. Diverticular disease: epidemiology and management. Can J Gastroenterol. 2011 Jul;25(7):385-9. doi: 10.1155/2011/795241.
- Background: PubMed 24509449Feingold D, Steele SR, Lee S, Kaiser A, Boushey R, Buie WD, Rafferty JF. Practice parameters for the treatment of sigmoid diverticulitis. Dis Colon Rectum. 2014 Mar;57(3):284-94. doi: 10.1097/DCR.0000000000000075. No abstract available.
- Background: PubMed 27138434Barat M, Dohan A, Pautrat K, Boudiaf M, Dautry R, Guerrache Y, Pocard M, Hoeffel C, Eveno C, Soyer P. Acute colonic diverticulitis: an update on clinical classification and management with MDCT correlation. Abdom Radiol (NY). 2016 Sep;41(9):1842-50. doi: 10.1007/s00261-016-0764-1.
- Background: PubMed 10399971Wasvary H, Turfah F, Kadro O, Beauregard W. Same hospitalization resection for acute diverticulitis. Am Surg. 1999 Jul;65(7):632-5; discussion 636.
- Background: PubMed 29204676Bates DDB, Fernandez MB, Ponchiardi C, von Plato M, Teich JP, Narsule C, Anderson SW, Gupta A, LeBedis CA. Surgical management in acute diverticulitis and its association with multi-detector CT, modified Hinchey classification, and clinical parameters. Abdom Radiol (NY). 2018 Aug;43(8):2060-2065. doi: 10.1007/s00261-017-1422-y.
- Background: PubMed 20645093Kaser SA, Fankhauser G, Glauser PM, Toia D, Maurer CA. Diagnostic value of inflammation markers in predicting perforation in acute sigmoid diverticulitis. World J Surg. 2010 Nov;34(11):2717-22. doi: 10.1007/s00268-010-0726-7.
- Background: PubMed 11723675Zahorec R. Ratio of neutrophil to lymphocyte counts--rapid and simple parameter of systemic inflammation and stress in critically ill. Bratisl Lek Listy. 2001;102(1):5-14. English, Slovak.
- Background: PubMed 28664739Zahorec R. Neutrophil-to-lymphocyte ratio. Sixteen-year-long history since publication of our article in Bratislava Medical Journal. Bratisl Lek Listy. 2017;118(6):321-323. doi: 10.4149/BLL_2017_062. No abstract available.
- Background: PubMed 29478743Miyamoto R, Inagawa S, Sano N, Tadano S, Adachi S, Yamamoto M. The neutrophil-to-lymphocyte ratio (NLR) predicts short-term and long-term outcomes in gastric cancer patients. Eur J Surg Oncol. 2018 May;44(5):607-612. doi: 10.1016/j.ejso.2018.02.003. Epub 2018 Feb 13.
- Background: PubMed 27941316Reynolds IS, Heaney RM, Khan W, Khan IZ, Waldron R, Barry K. The Utility of Neutrophil to Lymphocyte Ratio as a Predictor of Intervention in Acute Diverticulitis. Dig Surg. 2017;34(3):227-232. doi: 10.1159/000450836. Epub 2016 Dec 10.
- Background: PubMed 27336407Hogan J, Sehgal R, Murphy D, O'Leary P, Coffey JC. Do Inflammatory Indices Play a Role in Distinguishing between Uncomplicated and Complicated Diverticulitis? Dig Surg. 2017;34(1):7-11. doi: 10.1159/000447250. Epub 2016 Jun 24.
- Background: PubMed 32856387Zager Y, Horesh N, Dan A, Aharoni M, Khalilieh S, Cordoba M, Nevler A, Gutman M, Rosin D. Associations of novel inflammatory markers with long-term outcomes and recurrence of diverticulitis. ANZ J Surg. 2020 Oct;90(10):2041-2045. doi: 10.1111/ans.16220. Epub 2020 Aug 28.
- Individual participant dataSharing planned: No. Due to the sensitive nature of the study, patients were assured that the raw data would remain confidential and would not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Diverticulitis, run by Clinica Universitaria Reina Fabiola, Universidad Catolica de Cordoba at 1 site in Argentina.
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 2 inclusion and 4 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 11 Dec 2020. 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 Argentina. 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?
Demographic variables (time frame: 2013-2018). 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 NCT04663490, which also lists 17 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 11 Dec 2020.