Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis

NCT07889544 | Recruiting

• 2 other identifiers: AA-PROADM-2026-012024-TBEK 2026/07-25
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Appendicitis

Keywords

Pro-Adrenomedullin; C-Reactive Protein; Neutrophil-to-Lymphocyte Ratio; Acute Appendicitis

Outcome Measures

Primary Outcomes (1)

• 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.

  At initial clinical assessment (baseline); diagnostic status confirmed during the index hospitalization.

Secondary Outcomes (4)

• Comparison of the Diagnostic Accuracy of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio

  At initial clinical assessment (baseline).

• Optimal Diagnostic Cutoff Value of Serum Pro-Adrenomedullin

  At initial clinical assessment (baseline).

• Predictive Performance of Serum Pro-Adrenomedullin for Complicated Acute Appendicitis

  From initial clinical assessment to completion of the index hospitalization.

• Independent Diagnostic Contribution of Serum Pro-Adrenomedullin

  At initial clinical assessment (baseline); diagnostic status confirmed during the index hospitalization.

Study Arms (2)

Acute Appendicitis

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

Healthy Controls

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

Interventions

Serum Pro-Adrenomedullin Measurement DIAGNOSTIC_TEST

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.

Acute Appendicitis; Healthy Controls

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• Adults aged 18 to 90 years.
• Patients presenting to the emergency department within 48 hours of the onset of abdominal pain, either directly or following referral from another healthcare institution with a diagnosis or suspicion of acute appendicitis.
• Patients undergoing appendectomy for acute appendicitis (acute appendicitis group).
• Individuals attending outpatient clinics for routine health evaluations without abdominal pain or active inflammatory disease (control group).
• Provision of informed consent for participation in the study.

You may not qualify if:

• Age younger than 18 years or older than 90 years.
• Use of antibiotics or systemic corticosteroids within the preceding month.
• Active malignancy.
• Immunosuppressive disease or ongoing immunosuppressive treatment.
• Abdominal surgery within the preceding three months.
• Heart failure, renal failure, or liver cirrhosis.
• Pregnancy or postpartum period.
• Inability to provide informed consent due to psychiatric disorders.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16310, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Scott AJ, Mason SE, Arunakirinathan M, Reissis Y, Kinross JM, Smith JJ. Risk stratification by the Appendicitis Inflammatory Response score to guide decision-making in patients with suspected appendicitis. Br J Surg. 2015 Apr;102(5):563-72. doi: 10.1002/bjs.9773. Epub 2015 Mar 2.

  PMID: 25727811 BACKGROUND

• Oikonomopoulou N, Miguez-Navarro C, Rivas-Garcia A, Garcia Gamiz M, Lopez-Lopez R, Oliver-Saez P, Riano-Mendez B, Farfan-Orte T, Lobato-Salinas Z, Rubies-Olives J, Llena-Isla P, Lancho-Monreal EM; PROADM-DOLOR ABDOMINAL of the research net of the Spanish Society of Pediatric Emergencies (RISEUP-SPERG). Assessment of proadrenomedullin as diagnostic or prognostic biomarker of acute appendicitis in children with acute abdominal pain. Am J Emerg Med. 2019 Jul;37(7):1289-1294. doi: 10.1016/j.ajem.2018.09.038. Epub 2018 Sep 26.

  PMID: 30287129 BACKGROUND

• Miguez C, Tomatis Souverbielle C, Haro A, Guerrero G, Perez-Egido L, Garcia-Gamiz M, Maranon R. Evaluation of proadrenomedullin as a diagnostic or prognostic biomarker of acute appendicitis in children. Am J Emerg Med. 2016 Dec;34(12):2298-2305. doi: 10.1016/j.ajem.2016.08.032. Epub 2016 Aug 16.

  PMID: 27609121 BACKGROUND

• Temur SA, Baydin A, Tuncel OK, Caliskan S, Yuruker SS. Pro-adrenomedullin: a novel diagnostic biomarker of acute appendicitis. Ulus Travma Acil Cerrahi Derg. 2026 Jan;32(1):26-33. doi: 10.14744/tjtes.2025.99491.

  PMID: 41821289 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Ugur Duman, MD

  University of Health Sciences Turkiye, Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ugur Duman, MD

CONTACT

+905458177971; ugur.duman@sbu.edu.tr

Ulas Karabay, MD

CONTACT

+905423157367; dr.ukarabay@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of General Surgery

Study Record Dates

• First Submitted: October 16, 2026
• First Posted: October 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 22, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)