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Systemic and Tissue Inflammatory Biomarkers in Acute Appendicitis (STIBAA)

3. november 2026 opdateret af: 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.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

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.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Observationel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye), 34668
        • Rekruttering
        • Haydarpaşa Numune Training and Research Hospital
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Emre B Akçay

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte

Gruppe / kohorte

En gruppe eller undergruppe af deltagere i et observationsstudie, der vurderes for biomedicinske eller sundhedsmæssige resultater.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum/Plasma Presepsin Levels
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
White Blood Cell Count
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Haydarpasa Numune Training and Research Hospital

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Studieleder: Ali Sürmelioğlu, Haydarpasa Numune Training and Research Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
12. juli 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
12. januar 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
27. maj 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
23. oktober 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
3. november 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
9. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
9. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
3. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
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Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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