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Systemic and Tissue Inflammatory Biomarkers in Acute Appendicitis (STIBAA)

3 de noviembre de 2026 actualizado por: Ali Sürmelioğlu, Haydarpasa Numune Training and Research Hospital

Evaluation of Systemic and Tissue Level Inflammatory Response in Acute Appendicitis Using Multiple Biomarkers

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:

  • How are inflammatory biomarkers in blood and appendix tissue associated with the severity of acute appendicitis?
  • Do these biomarkers differ between patients with uncomplicated and complicated acute appendicitis?
  • Are inflammatory biomarker levels associated with clinical findings and commonly used laboratory indicators? Approximately 140 adult patients diagnosed with acute appendicitis and undergoing appendectomy will be included in the study.

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.

Descripción general del estudio

Estado

Estado

Indica el estado de contratación actual o el estado de acceso ampliado.
Reclutamiento

Condiciones

Condiciones

La enfermedad, trastorno, síndrome, dolencia o lesión que se está estudiando. En ClinicalTrials.gov, las condiciones también pueden incluir otros problemas relacionados con la salud, como la esperanza de vida, la calidad de vida y los riesgos para la salud.

Intervención / Tratamiento

Intervención / Tratamiento

Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.

Descripción detallada

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.

Tipo de estudio

Tipo de estudio

Describe la naturaleza de un estudio clínico. Los tipos de estudio incluyen estudios de intervención (también llamados ensayos clínicos), estudios observacionales (incluidos registros de pacientes) y acceso ampliado.
De observación

Inscripción (Estimado)

Inscripción

El número de participantes en un estudio clínico. La inscripción "anticipada" es el número objetivo de participantes que los investigadores necesitan para el estudio.
60

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Estudio Contacto

El nombre y la información de contacto de la persona que puede responder las preguntas de inscripción para un estudio clínico. Cada ubicación donde se lleva a cabo el estudio también puede tener un contacto específico, que puede responder mejor a esas preguntas.

Ubicaciones de estudio

  • Turquía (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turquía (Türkiye), 34668
        • Reclutamiento
        • Haydarpaşa Numune Training and Research Hospital
        • Contacto:
        • Contacto:
          • Ali Sürmelioğlu
          • Número de teléfono: +90 505 562 55 46
          • Correo electrónico: surmeliali@yahoo.com
        • Sub-Investigador:
          • Emre B Akçay

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Criterio de elegibilidad

Los principales requisitos que deben cumplir las personas que quieran participar en un estudio clínico o las características que deben tener. Los criterios de elegibilidad consisten en criterios de inclusión (que se requieren para que una persona participe en el estudio) y criterios de exclusión (que impiden que una persona participe). Los tipos de criterios de elegibilidad incluyen si un estudio acepta voluntarios sanos, tiene requisitos de edad o grupo de edad, o está limitado por sexo.

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

Inclusion Criteria:

Adults aged 18-65 years. Willingness to participate in the study and provision of written informed consent.

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 informed consent. 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 autoimmune diseases, including rheumatoid arthritis, inflammatory bowel disease, or systemic lupus erythematosus.

History of malignancy or active malignancy. Chronic renal failure or advanced liver failure. Use of immunosuppressive therapy. Use of corticosteroids, 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte

Grupo / Cohorte

Un grupo o subgrupo de participantes en un estudio observacional en el que se evalúan los resultados biomédicos o de salud.
Intervención / Tratamiento

Intervención / Tratamiento

Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.
Patients Undergoing Appendectomy for Acute Appendicitis

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.
Procedimiento: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medidas de resultado primarias

En el protocolo de un estudio clínico, la medida de resultado planificada que es la más importante para evaluar el efecto de una intervención/tratamiento. La mayoría de los estudios clínicos tienen una medida de resultado primaria, pero algunos tienen más de una.
Medida de resultado
Medida Descripción
Periodo de tiempo
Serum/Plasma Presepsin Levels
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue Presepsin Levels
Periodo de tiempo: During appendectomy (single tissue collection).

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.
During appendectomy (single tissue collection).
Serum/Plasma CD68 Levels
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue CD68 Levels
Periodo de tiempo: During appendectomy (single tissue collection).

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.
During appendectomy (single tissue collection).
Serum/Plasma COX-2 Levels
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue COX-2 Levels
Periodo de tiempo: During appendectomy (single tissue sampling).

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.
During appendectomy (single tissue sampling).
Serum/Plasma iNOS Levels
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue iNOS Levels
Periodo de tiempo: During appendectomy (single tissue sampling).

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.
During appendectomy (single tissue sampling).
Serum/Plasma TGF-β Levels
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue TGF-β Levels
Periodo de tiempo: During appendectomy (single tissue sampling).

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.
During appendectomy (single tissue sampling).
Serum/Plasma Calprotectin Levels
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue Calprotectin Levels
Periodo de tiempo: During appendectomy (single tissue sampling).

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.
During appendectomy (single tissue sampling).
Serum/Plasma Isoprostane Levels
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Appendix Tissue Isoprostane Levels
Periodo de tiempo: During appendectomy (single tissue sampling).

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.
During appendectomy (single tissue sampling).

Medidas de resultado secundarias

Medidas de resultado secundarias

En el protocolo de un estudio clínico, una medida de resultado planificada que no es tan importante como la medida de resultado primaria para evaluar el efecto de una intervención pero que sigue siendo de interés. La mayoría de los estudios clínicos tienen más de una medida de resultado secundaria.
Medida de resultado
Medida Descripción
Periodo de tiempo
White Blood Cell Count
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Absolute Neutrophil Count
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Absolute Lymphocyte Count
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Platelet Count
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Hemoglobin Concentration
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Hematocrit
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
C-Reactive Protein (CRP) Concentration
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Procalcitonin Concentration
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Ferritin Concentration
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Erythrocyte Sedimentation Rate (ESR)
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Neutrophil-to-Lymphocyte Ratio (NLR)
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Platelet-to-Lymphocyte Ratio (PLR)
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Systemic Immune-Inflammation Index (SII)
Periodo de tiempo: Preoperatively, before appendectomy (single blood sampling).

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.
Preoperatively, before appendectomy (single blood sampling).
Alvarado Score
Periodo de tiempo: Preoperatively, before appendectomy (single clinical assessment).

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.
Preoperatively, before appendectomy (single clinical assessment).
Appendicitis Inflammatory Response (AIR) Score
Periodo de tiempo: Preoperatively, before appendectomy (single clinical assessment).

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.
Preoperatively, before appendectomy (single clinical assessment).
Incidence of Postoperative Complications
Periodo de tiempo: From appendectomy through postoperative day 30.

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.
From appendectomy through postoperative day 30.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Patrocinador

La organización o persona que inicia el estudio y que tiene autoridad y control sobre el estudio.
Haydarpasa Numune Training and Research Hospital

Investigadores

Investigadores

Un investigador involucrado en un estudio clínico. Los términos relacionados incluyen investigador principal del sitio, subinvestigador del sitio, presidente del estudio, director del estudio e investigador principal del estudio.
  • Director de estudio: Ali Sürmelioğlu, Haydarpasa Numune Training and Research Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

Inicio del estudio

La fecha real en la que el primer participante se inscribió en un estudio clínico. La fecha de inicio "anticipada" del estudio es la fecha que los investigadores creen que será la fecha de inicio del estudio.
12 de julio de 2026

Finalización primaria (Estimado)

Finalización primaria

La fecha en la que el último participante en un estudio clínico fue examinado o recibió una intervención para recopilar datos finales para la medida de resultado primaria. Si el estudio clínico terminó de acuerdo con el protocolo o se terminó, no afecta esta fecha. Para estudios clínicos con más de una medida de resultado primaria con diferentes fechas de finalización, este término se refiere a la fecha en que se completa la recopilación de datos para todas las medidas de resultado primarias. La fecha de finalización principal "anticipada" es la fecha que los investigadores creen que será la fecha de finalización principal del estudio.
12 de enero de 2027

Finalización del estudio (Estimado)

Finalización del estudio

La fecha en la que el último participante en un estudio clínico fue examinado o recibió una intervención/tratamiento para recopilar los datos finales de las medidas de resultado primarias, las medidas de resultado secundarias y los eventos adversos (es decir, la última visita del último participante). La fecha de finalización "anticipada" del estudio es la fecha que los investigadores creen que será la fecha de finalización del estudio.
27 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

Enviado por primera vez

La fecha en la que el patrocinador o investigador del estudio envió por primera vez un registro del estudio a ClinicalTrials.gov. Por lo general, hay un retraso de unos días entre la primera fecha de envío y la disponibilidad del registro en ClinicalTrials.gov (la primera fecha publicada).
23 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

Primero enviado que cumplió con los criterios de control de calidad

La fecha en la que el patrocinador del estudio o el investigador envía por primera vez un registro del estudio que es consistente con los criterios de revisión de control de calidad (QC) de la Biblioteca Nacional de Medicina (NLM). Es posible que el patrocinador o el investigador deba revisar y enviar un registro de estudio una o más veces antes de que se cumplan los criterios de revisión de control de calidad de la NLM. Es responsabilidad del patrocinador o investigador asegurarse de que el registro del estudio sea coherente con los criterios de revisión de control de calidad de la NLM.
3 de noviembre de 2026

Publicado por primera vez (Actual)

Publicado por primera vez

La fecha en la que el registro del estudio estuvo disponible por primera vez en ClinicalTrials.gov después de que concluyó la revisión de control de calidad (QC) de la Biblioteca Nacional de Medicina (NLM). Por lo general, hay una demora de unos días entre la fecha en que el patrocinador del estudio o el investigador envió el registro del estudio y la primera fecha publicada.
9 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

Última actualización publicada

La fecha más reciente en la que se pusieron a disposición los cambios en un registro del estudio en ClinicalTrials.gov. Puede haber una demora entre el momento en que el patrocinador o el investigador del estudio envió los cambios a ClinicalTrials.gov (la fecha de envío de la última actualización) y la fecha de publicación de la última actualización.
9 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

Última actualización enviada que cumplió con los criterios de control de calidad

La fecha más reciente en la que el patrocinador del estudio o el investigador presentó cambios en un registro del estudio que son consistentes con los criterios de revisión de control de calidad (QC) de la Biblioteca Nacional de Medicina (NLM). Es responsabilidad del patrocinador o investigador asegurarse de que el registro del estudio sea coherente con los criterios de revisión de control de calidad de la NLM.
3 de noviembre de 2026

Última verificación

Última verificación

La fecha más reciente en la que el patrocinador o investigador del estudio confirmó que la información sobre un estudio clínico en ClinicalTrials.gov es precisa y actual. Si un estudio con un estado de reclutamiento de reclutamiento; aún no está reclutando; o activo, no se ha confirmado el reclutamiento en los últimos 2 años, el estado de reclutamiento del estudio se muestra como desconocido.
1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

Otros números de identificación del estudio

Identificadores o números de identificación distintos del número NCT que el patrocinador del estudio, los financiadores u otros asignan a un estudio clínico. Estos números pueden incluir identificadores únicos de otros registros de ensayos y números de subvención de los Institutos Nacionales de Salud.
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Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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