Acute AppendicitisNCT05033249
The Utility of Immature Granulocyte Count on the Prediction of Acute Appendicitis in the Suspected Acute Appendicitis
An observational study of Acute Appendicitis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Acute appendicitis is the most common cause of abdominal pain requiring surgery in the emergency department. The whole life acute appendicitis rate is 7%. Only half of the patients with acute appendicitis are presented with typical periumbilical pain following by nausea, vomiting, and the migration of pain to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Immature granulocyte count and Immature granulocyte percentage
- How many people
- 186 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jul 2019
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with abdominal pain admitted to the emergency room and whose calculated ALVARADO score was between 4 and 7. According to this result computed tomographic evaluation applied to these patients.
Who may be able to join
- Age > 18 years
- Patients complaining about abdominal pain
- Calculated ALVARADO Score 4-7
- Whose initial imaging technique was CT
Who cannot join
- Patients diagnosed with other imaging methods (eg, ultrasonography)
- Patients who underwent surgery without imaging modalities
- Patients who were followed by medical treatment without surgery
- Pregnant patients
- Age <18
- Patients with incomplete medical records
- Patients with additional diseases which can affect the blood parameters (such as underlying hematologic or rheumatologic disease, laignancies, other concurrent infectious diseases)
- Patients whom were treated with granulocyte colony-stimulating factors, glucocorticoids, or other immunosuppressants that may affect inflammation markers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University
Kahramanmaraş, 46000
About this study
Official title: The Utility of Immature Granulocyte Count and Percentage on the Prediction of Acute Appendicitis in the Suspected Acute Appendicitis According to the ALVARADO Scoring System: A Retrospective Cohort Study
Acute appendicitis is the most common cause of abdominal pain requiring surgery in the emergency department. The whole life acute appendicitis rate is 7%. Only half of the patients with acute appendicitis are presented with typical periumbilical pain following by nausea, vomiting, and the migration of pain to the right lower quadrant. The diagnosis of acute appendicitis is based on the patient's medical history, physical examination, and laboratory findings. The Alvarado scoring system (ASS), recommends discharge, observation, and surgical intervention to patients. However, such scoring systems should not be used as the only method in diagnosis. Increased imaging use in patients with suspected acute appendicitis improved the rate of correct diagnosis. American College of Radiology Appropriateness Criteria (ACR) recommends computerized tomography (CT) as the primary imaging method to confirm the diagnosis of acute appendicitis in adults. However, CT imaging has some disadvantages, such as radiation exposure, undesirable effects associated with the use of contrast agents, and increased workload in the emergency room. The count of immature granulocytes (IGC), which is an indicator of increased activation of the bone marrow, and the percentage of IG (IGP), which is the ratio of IGs to the total white blood cell count, are also has been used differentiation of complicated acute appendicitis from uncomplicated acute appendicitis, and other inflammatory pathologies. Nowadays automatic blood analyzers can easily measure the amount and percentage of IGs simultaneously in a complete blood count test with advances in technology.
It is aimed to investigate the utility of IGC and IGP on the prediction of suspected acute appendicitis according to the ASS and its effect on the need for CT scanning.
Read the detailed description
Acute appendicitis is the most common cause of abdominal pain requiring surgery in the emergency department. The highest incidence of acute appendicitis is in the 2nd and 3rd decades of life, but it can be seen at any age. There is a 7% chance that a person will have appendicitis during life. Only half of the patients with acute appendicitis are presented with typical periumbilical pain following by nausea, vomiting, and the migration of pain to the right lower quadrant. The diagnosis of acute appendicitis is based on the patient's medical history, physical examination, and laboratory findings. Various clinical prediction rules have been developed to increase diagnostic accuracy. The most accepted among these is the Alvarado scoring system (ASS). ASS classifies patients as low, moderate, and high-risk groups for acute appendicitis. Accordingly, it recommends discharge, observation, and surgical intervention to patients. However, such scoring systems should not be used as the only method in diagnosis.
Increased imaging use in patients with suspected acute appendicitis improved the rate of correct diagnosis. American College of Radiology Appropriateness Criteria (ACR) recommends computerized tomography (CT) as the primary imaging method to confirm the diagnosis of acute appendicitis in adults. However, CT imaging has some disadvantages, such as radiation exposure, undesirable effects associated with the use of contrast agents, and increased workload in the emergency room.
Numerous inflammatory parameters adapted from complete blood count parameters can be used in infectious inflammatory processes such as acute appendicitis, pyelonephritis, and non-infectious conditions such as differentiation of tumoral masses from benign lesions, and determining survival in acute myocardial infarction. Among these parameters, neutrophil-lymphocyte ratio, platelet lymphocyte ratio, and lymphocyte monocyte ratio were used in previous studies. Similarly, the number of immature granulocytes (IGC), which is an indicator of increased activation of the bone marrow, and the percentage of IG (IGP), which is the ratio of IGs to the total white blood cell count, are also has been used in acute necrotizing pancreatitis, differentiation of complicated acute appendicitis from uncomplicated acute appendicitis, pyelonephritis, sepsis, thyroid gland malignancies, and renal cell carcinomas. Previously the determination of the number of IGs could be possible based on counting granulocyte precursor cells during the direct microscopic examination. Nowadays automatic blood analyzers can easily measure the amount and percentage of IGs simultaneously in a complete blood count test with advances in technology. Immature granulocyte (IG) in peripheral blood is an indicator of increased bone marrow activity. It has been reported in previous studies that IGC and IGP increase in infection and sepsis, and are more reliable markers in the diagnosis of acute appendicitis than other hematological parameters.
This study aimed to investigate the utility of IGC and IGP on the prediction of suspected acute appendicitis according to the ASS and its effect on the need for CT scanning.
MATERIALS AND METHODS Study design and setting This study is a retrospective cohort analysis involving adult patients who were admitted to the emergency department of a university hospital between January 2019 and July 2019 due to abdominal pain and suspected acute appendicitis according to ASS. Local ethics committee approval was received for the study (ethics committee approval number 2019/11/06). Because the study design is retrospective, the signed informed consent of patients is not required. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
Patient Selection and Data Collection Adult patients who admitted to the Emergency Department of Kahramanmaras Sutcu Imam University hospital due to abdominal pain and had an ASS between 4-7, and whose initial imaging technique was CT were included in the study. ASS scores of the patients were calculated retrospectively by examining patients' medical records. Patients were used other imaging methods, underwent surgery without imaging, followed by medical treatment without surgery, pregnant, under the age of 18, with incomplete medical records, and with additional diseases (such as underlying hematologic or rheumatologic disease, other concurrent infectious diseases) and treated with granulocyte colony-stimulating factors, glucocorticoids, or other immunosuppressants that may affect inflammation markers were excluded from the study.
Electronic files of the patients recorded in the hospital database were reviewed by the investigators. Demographic data (age, gender), laboratory values, tomography reports, and pathological diagnoses were recorded. The diagnosis was also confirmed histopathologically in all patients diagnosed with acute appendicitis according to the result of tomography.
The white blood cell count (WBC), neutrophil count, lymphocyte count, IGC, and IGP were obtained from the blood sample taken at the time of the patient's first admission to the hospital using the Sysmex XN-3000 (Sysmex Corporation, Kobe, Japan) device. Neutrophil/lymphocyte ratio (NLR) was calculated manually from hemogram results. The patients were divided into two groups as those with acute appendicitis (appendicitis positive group, Group-P) and non-appendicitis (appendicitis negative group, Group-N) according to the result of tomography.
Statistical analysis The data were analyzed with the IBM Statistical Package for the Social Sciences (SPSS ver. 20) program. The compliance of continuous variables to normal distribution was evaluated with the Shapiro-Wilk test. An independent sample t-test was used to compare the data that complied with the normal distribution and the Mann Whitney-U test was used for those that did not comply with the normal distribution. Pearson test was used for correlation analysis of normally distributed parameters, and the Spearman test was used for correlation analysis of non-normally distributed parameters. Multivariate analysis was performed with parameters found to be significant in the evaluation of univariate analysis and predictive values of preoperative blood parameters were calculated. The Chi-square test was used to analyze categorical variables. p<0.05 value was considered significant. The Receiver Operating Characteristic (ROC) curve analysis was used to evaluate the success of laboratory parameters in predicting acute appendicitis diagnosis. The area under the curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy rate were calculated for parameters with a statistically significant difference between groups.
- Conditions
- Acute Appendicitis
- Being tested
- Immature granulocyte count, Immature granulocyte percentage
- Keywords
- Acute appendicitis, Computed Tomography, Immature granulocyte count, Immature granulocyte percentage, Alvarado Scoring System
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immature granulocyte countDiagnostic test
Automatically calculated immature granulocyte count in white blood cell count
Immature granulocyte percentageDiagnostic test
Automatically calculated immature granulocyte percentage in white blood cell count
| Study group | Role | What they receive |
|---|---|---|
| Normal | Alvarado Score 4 - 7 Normal according to the initial computed tomographic evaluation Receives: Diagnostic Test: Immature granulocyte count; Diagnostic Test: Immature granulocyte percentage | |
| Patient | Alvarado Score 4 - 7 Acute appendicitis according to the initial computed tomographic evaluation Receives: Diagnostic Test: Immature granulocyte count; Diagnostic Test: Immature granulocyte percentage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The utility of Immature granulocyte count on determining clinically suspected acute appendicitis cases and diminishing computed tomography need
Automatically counted immature granulocyte count can help to determine acute appendicitis cases and diminish the need for computed tomography in patients who admitted to the emergency room and ALVARADO score between 4 - 7.
Measured: January 2019 - July 2019
The utility of Immature granulocyte percentage on determining clinically suspected acute appendicitis cases and diminishing computed tomography need
Automatically calculated immature granulocyte percentage can help to determine acute appendicitis cases and diminish the need for computed tomography in patients who admitted to the emergency room and ALVARADO score between 4 - 7.
Measured: January 2019 - July 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Jan 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies 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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Collaborators
- Özlem Güler, Filiz Alkan Baylan
- Responsible party
- Principal investigator, Mehmet Buğra Bozan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033249
- Sponsor's protocol ID
- 181
- Status last verified
- Feb 2024
- First submitted
- 19 Jun 2021
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ohle R, O'Reilly F, O'Brien KK, Fahey T, Dimitrov BD. The Alvarado score for predicting acute appendicitis: a systematic review. BMC Med. 2011 Dec 28;9:139. doi: 10.1186/1741-7015-9-139.
PubMed 22204638Hosseini M, Tizmaghz A, Shabestanipour G, Aein A, Otaghvar H. The Frequency of Different Clinical Presentation of Appendicitis, Complications and Prognosis in Elderly. Annu Res Rev Biol. 2014;4(24):4381-8
Shuaib A, Shuaib A, Fakhra Z, Marafi B, Alsharaf K, Behbehani A. Evaluation of modified Alvarado scoring system and RIPASA scoring system as diagnostic tools of acute appendicitis. World J Emerg Med. 2017;8(4):276-280. doi: 10.5847/wjem.j.1920-8642.2017.04.005.
PubMed 29123605Dal F, Cicek Y, Pekmezci S, Kocazeybek B, Tokman HB, Konukoglu D, Simsek O, Taner Z, Sirekbasan S, Uludag SS. Role of Alvarado score and biological indicators of C-reactive protein, procalicitonin and neopterin in diagnosis of acute appendicitis. Ulus Travma Acil Cerrahi Derg. 2019 May;25(3):229-237. doi: 10.5505/tjtes.2018.57362.
PubMed 31135946Tintinalli JE, Stapczynski JS, Ma OJ, Cline DM, Cydulka Rk MG, editor. Gastrointestinal Emergencies. In: Tintinalli's Emergency Medicine: A Comprehensive Study Guide. 7th ed. New York: McGraw-Hill Medical; 2010
Rosen MP, Ding A, Blake MA, Baker ME, Cash BD, Fidler JL, Grant TH, Greene FL, Jones B, Katz DS, Lalani T, Miller FH, Small WC, Spottswood S, Sudakoff GS, Tulchinsky M, Warshauer DM, Yee J, Coley BD. ACR Appropriateness Criteria(R) right lower quadrant pain--suspected appendicitis. J Am Coll Radiol. 2011 Nov;8(11):749-55. doi: 10.1016/j.jacr.2011.07.010.
PubMed 22051456Smith MP, Katz DS, Lalani T, Carucci LR, Cash BD, Kim DH, Piorkowski RJ, Small WC, Spottswood SE, Tulchinsky M, Yaghmai V, Yee J, Rosen MP. ACR Appropriateness Criteria(R) Right Lower Quadrant Pain--Suspected Appendicitis. Ultrasound Q. 2015 Jun;31(2):85-91. doi: 10.1097/RUQ.0000000000000118.
PubMed 25364964Unal Y, Barlas AM. Role of increased immature granulocyte percentage in the early prediction of acute necrotizing pancreatitis. Ulus Travma Acil Cerrahi Derg. 2019 Mar;25(2):177-182. doi: 10.14744/tjtes.2019.70679.
PubMed 30892679Unal Y. A new and early marker in the diagnosis of acute complicated appendicitis: immature granulocytes. Ulus Travma Acil Cerrahi Derg. 2018 Sep;24(5):434-439. doi: 10.5505/tjtes.2018.91661.
PubMed 30394497Bozan MB, Yazar FM, Kale IT, Yuzbasioglu MF, Boran OF, Azak Bozan A. Delta Neutrophil Index and Neutrophil-to-Lymphocyte Ratio in the Differentiation of Thyroid Malignancy and Nodular Goiter. World J Surg. 2021 Feb;45(2):507-514. doi: 10.1007/s00268-020-05822-6. Epub 2020 Oct 16.
PubMed 33067685Barut O, Demirkol MK, Bilecan EB, Sahinkanat T, Resim S. The Delta Neutrophil Index is an Early Predictive Marker of Acute Pyelonephritis in Patients with Ureteral Stone. J Coll Physicians Surg Pak. 2020 Nov;30(11):1149-1154. doi: 10.29271/jcpsp.2020.11.1149.
PubMed 33222730Kong T, Park YS, Lee HS, Kim S, Lee JW, You JS, Chung HS, Park I, Chung SP. The delta neutrophil index predicts development of multiple organ dysfunction syndrome and 30-day mortality in trauma patients admitted to an intensive care unit: a retrospective analysis. Sci Rep. 2018 Nov 30;8(1):17515. doi: 10.1038/s41598-018-35796-4.
PubMed 30504778Shin DH, Cho YS, Cho GC, Ahn HC, Park SM, Lim SW, Oh YT, Cho JW, Park SO, Lee YH. Delta neutrophil index as an early predictor of acute appendicitis and acute complicated appendicitis in adults. World J Emerg Surg. 2017 Jul 24;12:32. doi: 10.1186/s13017-017-0140-7. eCollection 2017.
PubMed 28747992Barut O, Demirkol MK, Kucukdurmaz F, Sahinkanat T, Resim S. Pre-treatment Delta Neutrophil Index as a Predictive Factor in Renal Cell Carcinoma. J Coll Physicians Surg Pak. 2021 Feb;31(2):156-161. doi: 10.29271/jcpsp.2021.02.156.
PubMed 33645181
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Immature Granulocyte Count and Percentage on the Prediction of Acute Appendicitis in the Suspected Acute Appendicitis According to the ALVARADO Scoring System: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05033249
- Acronym / sponsor ID
- 181
- Conditions
- Acute Appendicitis
- Keywords
- Acute appendicitis, Computed Tomography, Immature granulocyte count, Immature granulocyte percentage, Alvarado Scoring System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Collaborators
- Özlem Güler, Filiz Alkan Baylan
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 2 Sep 2021 (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.
Acute appendicitis is the most common cause of abdominal pain requiring surgery in the emergency department. The whole life acute appendicitis rate is 7%. Only half of the patients with acute appendicitis are presented with typical periumbilical pain following by nausea, vomiting, and the migration of pain to the right lower quadrant. The diagnosis of acute appendicitis is based on the patient's medical history, physical examination, and laboratory findings. The Alvarado scoring system (ASS), recommends discharge, observation, and surgical intervention to patients. However, such scoring systems should not be used as the only method in diagnosis. Increased imaging use in patients with suspected acute appendicitis improved the rate of correct diagnosis. American College of Radiology Appropriateness Criteria (ACR) recommends computerized tomography (CT) as the primary imaging method to confirm the diagnosis of acute appendicitis in adults. However, CT imaging has some disadvantages, such as radiation exposure, undesirable effects associated with the use of contrast agents, and increased workload in the emergency room. The count of immature granulocytes (IGC), which is an indicator of increased activation of the bone marrow, and the percentage of IG (IGP), which is the ratio of IGs to the total white blood cell count, are also has been used differentiation of complicated acute appendicitis from uncomplicated acute appendicitis, and other inflammatory pathologies. Nowadays automatic blood analyzers can easily measure the amount and percentage of IGs simultaneously in a complete blood count test with advances in technology.
It is aimed to investigate the utility of IGC and IGP on the prediction of suspected acute appendicitis according to the ASS and its effect on the need for CT scanning.
Detailed description
Acute appendicitis is the most common cause of abdominal pain requiring surgery in the emergency department. The highest incidence of acute appendicitis is in the 2nd and 3rd decades of life, but it can be seen at any age. There is a 7% chance that a person will have appendicitis during life. Only half of the patients with acute appendicitis are presented with typical periumbilical pain following by nausea, vomiting, and the migration of pain to the right lower quadrant. The diagnosis of acute appendicitis is based on the patient's medical history, physical examination, and laboratory findings. Various clinical prediction rules have been developed to increase diagnostic accuracy. The most accepted among these is the Alvarado scoring system (ASS). ASS classifies patients as low, moderate, and high-risk groups for acute appendicitis. Accordingly, it recommends discharge, observation, and surgical intervention to patients. However, such scoring systems should not be used as the only method in diagnosis.
Increased imaging use in patients with suspected acute appendicitis improved the rate of correct diagnosis. American College of Radiology Appropriateness Criteria (ACR) recommends computerized tomography (CT) as the primary imaging method to confirm the diagnosis of acute appendicitis in adults. However, CT imaging has some disadvantages, such as radiation exposure, undesirable effects associated with the use of contrast agents, and increased workload in the emergency room.
Numerous inflammatory parameters adapted from complete blood count parameters can be used in infectious inflammatory processes such as acute appendicitis, pyelonephritis, and non-infectious conditions such as differentiation of tumoral masses from benign lesions, and determining survival in acute myocardial infarction. Among these parameters, neutrophil-lymphocyte ratio, platelet lymphocyte ratio, and lymphocyte monocyte ratio were used in previous studies. Similarly, the number of immature granulocytes (IGC), which is an indicator of increased activation of the bone marrow, and the percentage of IG (IGP), which is the ratio of IGs to the total white blood cell count, are also has been used in acute necrotizing pancreatitis, differentiation of complicated acute appendicitis from uncomplicated acute appendicitis, pyelonephritis, sepsis, thyroid gland malignancies, and renal cell carcinomas. Previously the determination of the number of IGs could be possible based on counting granulocyte precursor cells during the direct microscopic examination. Nowadays automatic blood analyzers can easily measure the amount and percentage of IGs simultaneously in a complete blood count test with advances in technology. Immature granulocyte (IG) in peripheral blood is an indicator of increased bone marrow activity. It has been reported in previous studies that IGC and IGP increase in infection and sepsis, and are more reliable markers in the diagnosis of acute appendicitis than other hematological parameters.
This study aimed to investigate the utility of IGC and IGP on the prediction of suspected acute appendicitis according to the ASS and its effect on the need for CT scanning.
MATERIALS AND METHODS Study design and setting This study is a retrospective cohort analysis involving adult patients who were admitted to the emergency department of a university hospital between January 2019 and July 2019 due to abdominal pain and suspected acute appendicitis according to ASS. Local ethics committee approval was received for the study (ethics committee approval number 2019/11/06). Because the study design is retrospective, the signed informed consent of patients is not required. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
Patient Selection and Data Collection Adult patients who admitted to the Emergency Department of Kahramanmaras Sutcu Imam University hospital due to abdominal pain and had an ASS between 4-7, and whose initial imaging technique was CT were included in the study. ASS scores of the patients were calculated retrospectively by examining patients' medical records. Patients were used other imaging methods, underwent surgery without imaging, followed by medical treatment without surgery, pregnant, under the age of 18, with incomplete medical records, and with additional diseases (such as underlying hematologic or rheumatologic disease, other concurrent infectious diseases) and treated with granulocyte colony-stimulating factors, glucocorticoids, or other immunosuppressants that may affect inflammation markers were excluded from the study.
Electronic files of the patients recorded in the hospital database were reviewed by the investigators. Demographic data (age, gender), laboratory values, tomography reports, and pathological diagnoses were recorded. The diagnosis was also confirmed histopathologically in all patients diagnosed with acute appendicitis according to the result of tomography.
The white blood cell count (WBC), neutrophil count, lymphocyte count, IGC, and IGP were obtained from the blood sample taken at the time of the patient's first admission to the hospital using the Sysmex XN-3000 (Sysmex Corporation, Kobe, Japan) device. Neutrophil/lymphocyte ratio (NLR) was calculated manually from hemogram results. The patients were divided into two groups as those with acute appendicitis (appendicitis positive group, Group-P) and non-appendicitis (appendicitis negative group, Group-N) according to the result of tomography.
Statistical analysis The data were analyzed with the IBM Statistical Package for the Social Sciences (SPSS ver. 20) program. The compliance of continuous variables to normal distribution was evaluated with the Shapiro-Wilk test. An independent sample t-test was used to compare the data that complied with the normal distribution and the Mann Whitney-U test was used for those that did not comply with the normal distribution. Pearson test was used for correlation analysis of normally distributed parameters, and the Spearman test was used for correlation analysis of non-normally distributed parameters. Multivariate analysis was performed with parameters found to be significant in the evaluation of univariate analysis and predictive values of preoperative blood parameters were calculated. The Chi-square test was used to analyze categorical variables. p<0.05 value was considered significant. The Receiver Operating Characteristic (ROC) curve analysis was used to evaluate the success of laboratory parameters in predicting acute appendicitis diagnosis. The area under the curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy rate were calculated for parameters with a statistically significant difference between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Diagnostic Test: Immature granulocyte count, Diagnostic Test: Immature granulocyte percentageAlvarado Score 4 - 7 Normal according to the initial computed tomographic evaluation |
| Patient | – | Diagnostic Test: Immature granulocyte count, Diagnostic Test: Immature granulocyte percentageAlvarado Score 4 - 7 Acute appendicitis according to the initial computed tomographic evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with abdominal pain admitted to the emergency room and whose calculated ALVARADO score was between 4 and 7. According to this result computed tomographic evaluation applied to these patients.
Key inclusion criteria (4 listed)
- Age > 18 years
- Patients complaining about abdominal pain
- Calculated ALVARADO Score 4-7
- Whose initial imaging technique was CT
Key exclusion criteria (8 listed)
- Patients diagnosed with other imaging methods (eg, ultrasonography)
- Patients who underwent surgery without imaging modalities
- Patients who were followed by medical treatment without surgery
- Pregnant patients
- Age <18
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 |
|---|---|---|
| Immature granulocyte countAutomatically calculated immature granulocyte count in white blood cell count | Diagnostic test | Normal, Patient |
| Immature granulocyte percentageAutomatically calculated immature granulocyte percentage in white blood cell count | Diagnostic test | Normal, Patient |
Primary outcome
The utility of Immature granulocyte count on determining clinically suspected acute appendicitis cases and diminishing computed tomography need
Time frame: January 2019 - July 2019
Automatically counted immature granulocyte count can help to determine acute appendicitis cases and diminish the need for computed tomography in patients who admitted to the emergency room and ALVARADO score between 4 - 7.
The utility of Immature granulocyte percentage on determining clinically suspected acute appendicitis cases and diminishing computed tomography need
Time frame: January 2019 - July 2019
Automatically calculated immature granulocyte percentage can help to determine acute appendicitis cases and diminish the need for computed tomography in patients who admitted to the emergency room and ALVARADO score between 4 - 7.
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 23 Feb 2024.
- Background: PubMed 22204638Ohle R, O'Reilly F, O'Brien KK, Fahey T, Dimitrov BD. The Alvarado score for predicting acute appendicitis: a systematic review. BMC Med. 2011 Dec 28;9:139. doi: 10.1186/1741-7015-9-139.
- BackgroundHosseini M, Tizmaghz A, Shabestanipour G, Aein A, Otaghvar H. The Frequency of Different Clinical Presentation of Appendicitis, Complications and Prognosis in Elderly. Annu Res Rev Biol. 2014;4(24):4381-8
- Background: PubMed 29123605Shuaib A, Shuaib A, Fakhra Z, Marafi B, Alsharaf K, Behbehani A. Evaluation of modified Alvarado scoring system and RIPASA scoring system as diagnostic tools of acute appendicitis. World J Emerg Med. 2017;8(4):276-280. doi: 10.5847/wjem.j.1920-8642.2017.04.005.
- Background: PubMed 31135946Dal F, Cicek Y, Pekmezci S, Kocazeybek B, Tokman HB, Konukoglu D, Simsek O, Taner Z, Sirekbasan S, Uludag SS. Role of Alvarado score and biological indicators of C-reactive protein, procalicitonin and neopterin in diagnosis of acute appendicitis. Ulus Travma Acil Cerrahi Derg. 2019 May;25(3):229-237. doi: 10.5505/tjtes.2018.57362.
- BackgroundTintinalli JE, Stapczynski JS, Ma OJ, Cline DM, Cydulka Rk MG, editor. Gastrointestinal Emergencies. In: Tintinalli's Emergency Medicine: A Comprehensive Study Guide. 7th ed. New York: McGraw-Hill Medical; 2010
- Background: PubMed 22051456Rosen MP, Ding A, Blake MA, Baker ME, Cash BD, Fidler JL, Grant TH, Greene FL, Jones B, Katz DS, Lalani T, Miller FH, Small WC, Spottswood S, Sudakoff GS, Tulchinsky M, Warshauer DM, Yee J, Coley BD. ACR Appropriateness Criteria(R) right lower quadrant pain--suspected appendicitis. J Am Coll Radiol. 2011 Nov;8(11):749-55. doi: 10.1016/j.jacr.2011.07.010.
- Background: PubMed 25364964Smith MP, Katz DS, Lalani T, Carucci LR, Cash BD, Kim DH, Piorkowski RJ, Small WC, Spottswood SE, Tulchinsky M, Yaghmai V, Yee J, Rosen MP. ACR Appropriateness Criteria(R) Right Lower Quadrant Pain--Suspected Appendicitis. Ultrasound Q. 2015 Jun;31(2):85-91. doi: 10.1097/RUQ.0000000000000118.
- Background: PubMed 30892679Unal Y, Barlas AM. Role of increased immature granulocyte percentage in the early prediction of acute necrotizing pancreatitis. Ulus Travma Acil Cerrahi Derg. 2019 Mar;25(2):177-182. doi: 10.14744/tjtes.2019.70679.
- Background: PubMed 30394497Unal Y. A new and early marker in the diagnosis of acute complicated appendicitis: immature granulocytes. Ulus Travma Acil Cerrahi Derg. 2018 Sep;24(5):434-439. doi: 10.5505/tjtes.2018.91661.
- Background: PubMed 33067685Bozan MB, Yazar FM, Kale IT, Yuzbasioglu MF, Boran OF, Azak Bozan A. Delta Neutrophil Index and Neutrophil-to-Lymphocyte Ratio in the Differentiation of Thyroid Malignancy and Nodular Goiter. World J Surg. 2021 Feb;45(2):507-514. doi: 10.1007/s00268-020-05822-6. Epub 2020 Oct 16.
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- Background: PubMed 30504778Kong T, Park YS, Lee HS, Kim S, Lee JW, You JS, Chung HS, Park I, Chung SP. The delta neutrophil index predicts development of multiple organ dysfunction syndrome and 30-day mortality in trauma patients admitted to an intensive care unit: a retrospective analysis. Sci Rep. 2018 Nov 30;8(1):17515. doi: 10.1038/s41598-018-35796-4.
- Individual participant dataSharing planned: Undecided
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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 Appendicitis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 8 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 23 Feb 2024. 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 Turkey (Türkiye). 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?
The utility of Immature granulocyte count on determining clinically suspected acute appendicitis cases and diminishing computed tomography need (time frame: January 2019 - July 2019). The study lists 2 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 NCT05033249, which also lists 14 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 23 Feb 2024.