An observational study in Acute Appendicitis, sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Bursa Yuksek Ihtisas Training and Research Hospital · Observational
This prospective, single-center, observational study aims to evaluate the diagnostic accuracy of serum pro-adrenomedullin (Pro-ADM) in adult patients with acute appendicitis and compare its diagnostic performance with conventional inflammatory biomarkers, particularly C-reactive protein (CRP) and the neutrophil-to-lymphocyte ratio (NLR).
Acute appendicitis is a common surgical emergency. However, its diagnosis can be challenging because symptoms and laboratory findings are often nonspecific. Although CRP, white blood cell count, and NLR are widely used in clinical practice, their diagnostic accuracy may be limited. Pro-ADM is a biomarker associated with inflammation and infection and may provide additional diagnostic information.
The study will prospectively enroll 400 adult participants at Bursa Yuksek Ihtisas Training and Research Hospital, Turkiye. The study population will include patients undergoing appendectomy for acute appendicitis and a control group of individuals without abdominal pain or active inflammatory disease.
Demographic characteristics, clinical findings, imaging results, and routine laboratory parameters will be recorded. Blood samples will be collected to determine serum Pro-ADM levels.
The diagnostic performance of Pro-ADM will be evaluated using receiver operating characteristic (ROC) curve analysis and compared with conventional inflammatory biomarkers. The study will also investigate the potential value of Pro-ADM in predicting complicated acute appendicitis.
The findings may help clarify whether Pro-ADM could serve as an additional biomarker in the diagnostic evaluation of acute appendicitis.
Background and Rationale:
Acute appendicitis is among the most common causes of emergency abdominal surgery. Despite advances in diagnostic imaging and laboratory testing, accurate diagnosis remains challenging, particularly in patients presenting with nonspecific symptoms or equivocal clinical findings. Conventional inflammatory biomarkers, including white blood cell count, C-reactive protein (CRP), and neutrophil-to-lymphocyte ratio (NLR), are frequently used to support clinical assessment. However, their individual diagnostic performance is limited, and additional biomarkers may improve diagnostic evaluation. Adrenomedullin (ADM) is a vasoactive peptide involved in vascular regulation, inflammation, and immune responses. Pro-adrenomedullin (Pro-ADM), a more stable precursor-related biomarker, has been investigated in several inflammatory and infectious conditions, including sepsis and pneumonia. Previous studies have examined the diagnostic potential of Pro-ADM in pediatric appendicitis. Limited evidence is available regarding its diagnostic performance in adult patients with acute appendicitis.
This study aims to investigate the diagnostic accuracy of Pro-ADM and compare its performance with routinely measured inflammatory biomarkers.
Study Design:
This is a prospective, single-center, observational, controlled study conducted at Bursa Yuksek Ihtisas Training and Research Hospital, Türkiye.
The planned enrollment is 400 adult participants aged 18-90 years.
Two study groups will be evaluated:
Participants will be enrolled prospectively after providing informed consent.
Clinical and Laboratory Assessment:
The following information will be collected:
Blood samples will be obtained for Pro-ADM measurement, and the results will be compared with conventional laboratory parameters.
Clinical management, diagnostic imaging, and surgical treatment will be performed according to routine clinical practice. The study will not assign participants to experimental treatments.
Study Objectives:
The primary objective is to determine the diagnostic accuracy of serum Pro-ADM in identifying acute appendicitis.
Secondary objectives include:
Statistical Analysis:
Descriptive statistics will be used to summarize demographic, clinical, and laboratory characteristics. Continuous variables will be expressed as mean and standard deviation or median and range, according to their distribution. Categorical variables will be presented as frequencies and percentages.
Appropriate statistical tests will be used for comparisons between groups. The chi-square test will be applied to categorical variables when appropriate.
Receiver operating characteristic (ROC) curve analysis will be performed to evaluate the diagnostic performance of Pro-ADM and conventional inflammatory biomarkers.
The area under the ROC curve (AUC) will be used to quantify diagnostic discrimination.
Diagnostic cutoff values will be explored, and sensitivity and specificity will be calculated.
Regression analyses will be performed to investigate the independent diagnostic contribution of Pro-ADM and its relationship with other clinical and laboratory variables.
Statistical analyses will be conducted using SPSS Statistics version 26.
Expected Significance:
This study is expected to provide additional evidence regarding the potential diagnostic utility of Pro-ADM in adult acute appendicitis. By comparing Pro-ADM with routinely available inflammatory biomarkers, the study aims to clarify its possible role as an adjunctive laboratory parameter in the diagnostic evaluation of acute appendicitis.
417 studies on the registry are indexed under Appendicitis; 63 are open to participants now.
This study's planned enrollment of 400 is above the median of 207 across 153 observational studies indexed under Appendicitis.
Browse Appendicitis studies →Bursa Yuksek Ihtisas Training and Research Hospital is the lead sponsor of 50 studies on the registry; 21 are open to participants now.
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The study population consists of adults aged 18-90 years evaluated at Bursa Yuksek Ihtisas Training and Research Hospital, Türkiye. The case group includes patients presenting to the emergency department within 48 hours of abdominal pain onset who undergo appendectomy for acute appendicitis. The control group consists of individuals attending outpatient clinics for routine health evaluations without abdominal pain or active inflammatory disease. A total of 400 participants will be prospectively enrolled after providing informed consent.
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Exclusion Criteria:
Adult patients aged 18-90 years presenting to the emergency department with suspected acute appendicitis who subsequently undergo appendectomy. Clinical characteristics, imaging findings, conventional inflammatory biomarkers, and serum pro-adrenomedullin (Pro-ADM) concentrations will be prospectively recorded. The diagnostic performance of Pro-ADM will be evaluated in comparison with conventional inflammatory biomarkers.
Diagnostic Test: Serum Pro-Adrenomedullin Measurement
Adult individuals aged 18-90 years attending outpatient clinics for routine health evaluations without abdominal pain or active inflammatory disease. Demographic characteristics and laboratory parameters, including serum pro-adrenomedullin (Pro-ADM), C-reactive protein (CRP), and neutrophil-to-lymphocyte ratio (NLR), will be evaluated for comparison with the acute appendicitis group.
Diagnostic Test: Serum Pro-Adrenomedullin Measurement
Blood samples will be collected from enrolled participants to measure serum pro-adrenomedullin (Pro-ADM) concentrations. Pro-ADM levels will be evaluated and compared with conventional inflammatory biomarkers, including C-reactive protein (CRP), white blood cell count, and neutrophil-to-lymphocyte ratio (NLR), to assess their diagnostic performance in acute appendicitis. The test is performed for research purposes and does not determine clinical treatment allocation.
Diagnostic Accuracy of Serum Pro-Adrenomedullin for Acute Appendicitis
The diagnostic accuracy of serum pro-adrenomedullin (Pro-ADM) for distinguishing patients with acute appendicitis from healthy controls will be assessed using the area under the receiver operating characteristic curve (AUC-ROC). Higher AUC values indicate better diagnostic discrimination. Sensitivity and specificity at the identified diagnostic cutoff will also be calculated.
Time frame: At initial clinical assessment (baseline); diagnostic status confirmed during the index hospitalization.
Comparison of the Diagnostic Accuracy of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio
The diagnostic performance of Pro-ADM, C-reactive protein (CRP), and neutrophil-to-lymphocyte ratio (NLR) will be evaluated using receiver operating characteristic (ROC) curve analysis. The area under the ROC curve (AUC) will be calculated for each biomarker, and their discriminatory performance for acute appendicitis will be compared.
Time frame: At initial clinical assessment (baseline).
Optimal Diagnostic Cutoff Value of Serum Pro-Adrenomedullin
A diagnostic cutoff value for serum Pro-ADM will be identified using receiver operating characteristic (ROC) curve analysis. Diagnostic sensitivity and specificity at the selected cutoff will be calculated to evaluate its ability to distinguish patients with acute appendicitis from healthy controls.
Time frame: At initial clinical assessment (baseline).
Predictive Performance of Serum Pro-Adrenomedullin for Complicated Acute Appendicitis
The ability of serum Pro-ADM concentrations to discriminate complicated from uncomplicated acute appendicitis will be evaluated among patients with acute appendicitis. Receiver operating characteristic (ROC) curve analysis will be used to assess discriminatory performance, expressed as the area under the curve (AUC).
Time frame: From initial clinical assessment to completion of the index hospitalization.
Independent Diagnostic Contribution of Serum Pro-Adrenomedullin
The independent association between serum Pro-ADM concentration and acute appendicitis diagnosis will be evaluated using multivariable regression analysis, adjusting for available conventional inflammatory biomarkers and relevant clinical variables. The adjusted effect estimate and its 95% confidence interval will be reported.
Time frame: At initial clinical assessment (baseline); diagnostic status confirmed during the index hospitalization.
Plan to share: No — Individual participant data (IPD) will not be made publicly available. The study involves clinical and laboratory data collected from patients and healthy volunteers at a single institution. To protect participant confidentiality and comply with applicable ethical and data protection requirements, individual-level data will not be shared with external researchers. Study findings will be reported in aggregate form through scientific publications and presentations.
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Bursa Yuksek Ihtisas Training and Research Hospital