An observational study in Acute Appendicitis, sponsored by Haydarpasa Numune Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Haydarpasa Numune Training and Research Hospital · Observational
This observational study aims to evaluate inflammatory responses in the blood and appendix tissue of adults diagnosed with acute appendicitis. Acute appendicitis is a common condition that often requires emergency surgery. Although clinical examinations, laboratory tests, and imaging methods are used for diagnosis, distinguishing uncomplicated from complicated appendicitis can sometimes be challenging.
The study aims to investigate whether inflammatory biomarkers measured in blood and appendix tissue are associated with the severity of acute appendicitis and whether these biomarkers may help improve the assessment of the disease.
The main questions this study aims to answer are:
Participants will receive standard medical and surgical care. Blood samples obtained during routine clinical care and appendix tissue samples collected during surgery will be used for additional laboratory analyses. No additional invasive procedures or changes to standard treatment will be required for research purposes.
The findings may help researchers better understand inflammatory processes in acute appendicitis and identify biomarkers that could support clinical assessment and decision-making.
Background and Rationale:
Acute appendicitis is one of the most common causes of acute abdominal pain requiring emergency surgical intervention. Accurate assessment of disease severity, particularly the differentiation between uncomplicated and complicated acute appendicitis, remains an important clinical challenge.
Although clinical scoring systems, laboratory parameters, and imaging modalities contribute to diagnosis and clinical decision-making, their individual diagnostic performance may be limited. Systemic inflammatory markers, including C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR), have been investigated as indicators of inflammatory activity. However, circulating inflammatory markers may not fully reflect the local inflammatory processes occurring within the appendix.
The simultaneous evaluation of systemic and tissue-level inflammatory biomarkers may provide a more comprehensive understanding of the inflammatory response in acute appendicitis and its relationship with disease severity.
Study Objective:
The primary objective of this prospective observational study is to evaluate systemic and tissue-level inflammatory responses in patients with acute appendicitis using multiple biomarkers.
The study will investigate the relationships between circulating inflammatory markers, local inflammatory biomarkers in appendix tissue, clinical findings, and the severity of acute appendicitis.
Study Design and Population:
This is a prospective, observational, single-center study conducted in the Department of General Surgery at Haydarpaşa Numune Training and Research Hospital, Istanbul, Türkiye.
Approximately 140 adult patients diagnosed with acute appendicitis and undergoing appendectomy will be enrolled according to the predefined eligibility criteria.
Patients will receive standard diagnostic evaluation and surgical treatment. No experimental therapeutic intervention or alteration of routine clinical management will be performed as part of the study.
Clinical Assessment:
Clinical and demographic information will be collected from eligible participants. Preoperative clinical evaluation will include the Alvarado Score and the Appendicitis Inflammatory Response (AIR) Score.
Clinical findings, routine laboratory results, imaging findings, operative observations, and histopathological examination results will be evaluated in relation to inflammatory biomarker measurements.
Biological Sample Collection and Biomarker Assessment:
Blood samples collected as part of routine clinical evaluation will be used for systemic inflammatory biomarker analysis. Serum or plasma obtained from these samples will be processed under appropriate laboratory conditions and stored at -80°C until analysis.
The systemic inflammatory parameters evaluated will include CRP, NLR, PLR, systemic inflammatory index, procalcitonin, ferritin, presepsin, erythrocyte sedimentation rate, CD68, cyclooxygenase-2 (COX-2), inducible nitric oxide synthase (iNOS), transforming growth factor-beta (TGF-β), calprotectin, and isoprostane.
Appendix tissue samples will be obtained from surgically removed specimens. Tissue collection will be performed without interfering with routine histopathological examination.
Tissue samples designated for biochemical analysis will be transported under cold-chain conditions, stored at -80°C, and homogenized using a standardized laboratory procedure.
Local inflammatory biomarkers assessed in appendix tissue will include presepsin, CD68, COX-2, iNOS, TGF-β, calprotectin, and isoprostane.
Statistical Analysis:
Statistical analyses will be performed using appropriate statistical software. The distribution of continuous variables will be assessed using the Kolmogorov-Smirnov or Shapiro-Wilk test. Normally distributed variables will be expressed as mean and standard deviation, whereas non-normally distributed variables will be presented as median and interquartile range.
Comparisons between groups will be performed using the independent-samples t-test or Mann-Whitney U test, as appropriate. Categorical variables will be analyzed using the chi-square test or Fisher's exact test.
For comparisons involving more than two groups, analysis of variance or the Kruskal-Wallis test will be used according to data distribution.
Correlations between inflammatory biomarkers and clinical scores will be assessed using Pearson or Spearman correlation analysis. Receiver operating characteristic (ROC) curve analysis will be used to evaluate the discriminatory performance of biomarkers for distinguishing complicated from uncomplicated acute appendicitis.
Multivariable logistic regression analysis will be considered to identify independent predictors of disease severity.
A p-value of less than 0.05 will be considered statistically significant.
Expected Scientific Contribution:
By evaluating circulating and tissue-level inflammatory biomarkers together, this study aims to provide a more comprehensive characterization of the inflammatory response in acute appendicitis.
The findings may contribute to identifying biomarkers associated with disease severity and may support future research on improved diagnostic assessment and clinical decision-making.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 151 observational studies indexed under Appendicitis.
Browse Appendicitis studies →Haydarpasa Numune Training and Research Hospital is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients presenting to the General Surgery Department of Haydarpaşa Numune Training and Research Hospital with suspected acute appendicitis and scheduled for appendectomy will constitute the study population. Participants will be recruited consecutively from patients undergoing routine clinical and surgical care at this hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults aged 18-65 years. Willingness to participate in the study and provision of written .
Suspected acute appendicitis based on clinical, laboratory, and/or imaging findings.
Scheduled for appendectomy following general surgical evaluation. Availability of an appendectomy specimen suitable for postoperative histopathological examination.
Availability of sufficient clinical and laboratory records for study evaluation.
Exclusion Criteria:
Age younger than 18 years or older than 65 years. Refusal to participate or failure to provide written . Presence of an active infection that may affect the systemic inflammatory response during the preoperative period.
Concomitant active infectious diseases, including pneumonia, urinary tract infection, or sepsis.
Chronic inflammatory or diseases, including rheumatoid arthritis, inflammatory bowel disease, or systemic lupus erythematosus.
History of or active malignancy. Chronic renal failure or advanced liver failure. Use of therapy. Use of , chemotherapy, or biological agents. Preoperative use of antibiotics or anti-inflammatory medications at a level that may significantly affect inflammatory biomarker measurements.
Pregnancy or breastfeeding. Identification of additional intra-abdominal pathology unrelated to appendicitis during appendectomy.
Failure to confirm acute appendicitis on postoperative histopathological examination.
Inadequate biological sample quantity or failure to store biological samples under appropriate conditions.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort includes adult patients undergoing appendectomy for acute appendicitis. Blood samples and appendix tissue specimens obtained during routine clinical care and surgery will be analyzed to evaluate systemic and tissue-level inflammatory biomarkers and their associations with clinical findings and disease severity. All participants will receive standard medical and surgical care without any research-related modifications to their treatment.
Procedure: appendectomy
Patients diagnosed with acute appendicitis will undergo appendectomy as part of routine clinical care. The surgical procedure will be performed according to standard clinical indications and will not be assigned or modified by the study protocol. Blood samples and surgically removed appendix tissue specimens will be used for inflammatory biomarker analyses. No experimental surgical intervention or modification of standard treatment will be performed.
Serum/Plasma Presepsin Levels
Presepsin concentrations will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma presepsin levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue Presepsin Levels
Presepsin levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
Time frame: During appendectomy (single tissue collection).
Serum/Plasma CD68 Levels
CD68 levels will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma CD68 levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue CD68 Levels
CD68 levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
Time frame: During appendectomy (single tissue collection).
Serum/Plasma COX-2 Levels
Cyclooxygenase-2 (COX-2) levels will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma COX-2 levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue COX-2 Levels
Cyclooxygenase-2 (COX-2) levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
Time frame: During appendectomy (single tissue sampling).
Serum/Plasma iNOS Levels
Inducible nitric oxide synthase (iNOS) levels will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma iNOS levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue iNOS Levels
Inducible nitric oxide synthase (iNOS) levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
Time frame: During appendectomy (single tissue sampling).
Serum/Plasma TGF-β Levels
Transforming growth factor-beta (TGF-β) levels will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma TGF-β levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue TGF-β Levels
Transforming growth factor-beta (TGF-β) levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
Time frame: During appendectomy (single tissue sampling).
Serum/Plasma Calprotectin Levels
Calprotectin concentrations will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma calprotectin levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic inflammatory responses and their association with the severity of acute appendicitis.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue Calprotectin Levels
Calprotectin concentrations will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local inflammatory responses and their association with the severity of acute appendicitis.
Time frame: During appendectomy (single tissue sampling).
Serum/Plasma Isoprostane Levels
Isoprostane levels will be measured in preoperative peripheral venous blood samples using commercially available ELISA kits according to the manufacturer's instructions. Serum or plasma isoprostane levels will be expressed in ng/mL (provisional unit, subject to confirmation based on the selected assay). The measurements will be used to evaluate systemic oxidative stress responses and their association with the severity of acute appendicitis.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue Isoprostane Levels
Isoprostane levels will be measured in appendix tissue homogenates prepared from surgically removed appendectomy specimens using commercially available ELISA kits according to the manufacturer's instructions. Results will be normalized to total tissue protein content and expressed in ng/mg total protein (provisional unit, subject to confirmation based on the selected assay and normalization method). The measurements will be used to evaluate local oxidative stress responses and their association with the severity of acute appendicitis.
Time frame: During appendectomy (single tissue sampling).
White Blood Cell Count
White blood cell count will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed as ×10³/µL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Absolute Neutrophil Count
Absolute neutrophil count will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed as ×10³/µL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Absolute Lymphocyte Count
Absolute lymphocyte count will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed as ×10³/µL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Platelet Count
Platelet count will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed as ×10³/µL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Hemoglobin Concentration
Hemoglobin concentration will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed in g/dL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Hematocrit
Hematocrit will be obtained from routine preoperative complete blood count results recorded in hospital laboratory records. Values will be expressed as a percentage (%) and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
C-Reactive Protein (CRP) Concentration
Preoperative C-reactive protein (CRP) concentration will be obtained from routine hospital laboratory records. Values will be expressed in mg/L and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Procalcitonin Concentration
Preoperative procalcitonin concentration will be obtained from available routine hospital laboratory records. Values will be expressed in ng/mL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Ferritin Concentration
Preoperative ferritin concentration will be obtained from available routine hospital laboratory records. Values will be expressed in ng/mL and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Erythrocyte Sedimentation Rate (ESR)
Preoperative erythrocyte sedimentation rate (ESR) will be obtained from available routine hospital laboratory records. Values will be expressed in mm/hour and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Neutrophil-to-Lymphocyte Ratio (NLR)
The neutrophil-to-lymphocyte ratio (NLR) will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count obtained from routine preoperative complete blood count results. NLR will be reported as a dimensionless ratio and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Platelet-to-Lymphocyte Ratio (PLR)
The platelet-to-lymphocyte ratio (PLR) will be calculated by dividing the platelet count by the absolute lymphocyte count obtained from routine preoperative complete blood count results. PLR will be reported as a dimensionless ratio and evaluated in relation to acute appendicitis severity and experimental inflammatory biomarker levels.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Systemic Immune-Inflammation Index (SII)
The systemic immune-inflammation index (SII) will be calculated as platelet count multiplied by absolute neutrophil count and divided by absolute lymphocyte count, using routine preoperative complete blood count results. Cell counts will be expressed in ×10³/µL for calculation, and SII will be reported in ×10³/µL. Associations with acute appendicitis severity and experimental inflammatory biomarker levels will be evaluated.
Time frame: Preoperatively, before appendectomy (single blood sampling).
Alvarado Score
The Alvarado score will be calculated using preoperative clinical findings and laboratory parameters. The total score ranges from 0 to 10 points, with higher scores indicating a greater clinical likelihood of acute appendicitis. Associations between the score and experimental inflammatory biomarker levels will be evaluated.
Time frame: Preoperatively, before appendectomy (single clinical assessment).
Appendicitis Inflammatory Response (AIR) Score
The Appendicitis Inflammatory Response (AIR) score will be calculated using preoperative clinical findings and laboratory parameters. The total score ranges from 0 to 12 points, with higher scores indicating a greater clinical likelihood of acute appendicitis. Associations between the score and experimental inflammatory biomarker levels will be evaluated.
Time frame: Preoperatively, before appendectomy (single clinical assessment).
Incidence of Postoperative Complications
The occurrence of postoperative complications following appendectomy will be assessed using hospital medical records. The outcome will be reported as the number and percentage of patients experiencing at least one postoperative complication during the predefined follow-up period.
Time frame: From appendectomy through postoperative day 30.
Plan to share: No — Individual participant data will not be shared with external researchers. Clinical, laboratory, and histopathological data will be coded and securely stored to protect participant confidentiality. Access to individual-level data will be restricted to the authorized research team. Study findings will be reported in aggregate form without disclosing identifiable participant information.
Started Jul 2026 (actual). Primary completion is estimated for Jan 2027, 6 months after the start.
Of 54 non-industry observational studies under Appendicitis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 56. This study's planned 6 months is below that.
Counting every sponsor, half of 56 studies reached it within 23 months; a quarter within 7 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Haydarpasa Numune Training and Research Hospital