NCT07002671

Brief Summary

Acute abdomen is a frequently encountered clinical condition that can be fatal if not diagnosed early. Acute appendicitis is one of the causes of acute abdomen and is the most common clinical condition leading to acute abdomen worldwide. Therefore, early diagnosis is crucial. Delays in diagnosis can lead to the complication of appendicitis and an increase in its complications, further worsening the clinical picture and raising morbidity and mortality rates. In patients diagnosed with acute appendicitis, distinguishing between complicated and uncomplicated appendicitis is vital for treatment planning. The evaluation of patients' laboratory and radiological findings are widely used methods in clinical practice for this differentiation. Recent studies have shown the HALP score has become a new prognostic biomarker in the literature, used to predict a range of clinical outcomes in various neoplasms. To date, the HALP score has been used to evaluate outcomes and prognosis in gastric, colorectal, bladder, prostate, and other cancers, as well as in many other diseases. The purpose of this study is to determine the clinical impact of using the preoperatively calculated HALP score, derived from blood parameters, in the diagnosis, detection, and treatment of complicated acute appendicitis cases in the preoperative period without the need for additional diagnostic methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

May 25, 2025

Last Update Submit

June 22, 2025

Conditions

Keywords

Acute AppendicitisComplicated Acute AppendicitisUncomplicated Acute AppendicitisHALP Score

Outcome Measures

Primary Outcomes (1)

  • Preoperative HALP Score

    Manually calculated HALP score from routinely obtained preoperative blood samples of acute appendicitis cases, can be helpful for preoperatively determining complicated acute appendicitis cases without additional cost.

    2020,01,01-2025,01,01

Secondary Outcomes (1)

  • Preoperative cut off value levels of HALP score to determine complicated acute appendicitis

    2020,01,01-2025,01,01

Study Arms (2)

Complicated acute appendicitis cases

Acute appendicitis cases with pathological diagnosis of gangrenous, phlegmonous, perforated or presence of perforation, abscess or plastron in surgical exploration

Procedure: AppendectomyDiagnostic Test: blood sampling

Uncomplicated acute appendicitis cases

Acute appendicitis cases without pathological diagnosis of gangrenous, phlegmonous, perforated or presence of perforation, abscess or plastron in surgical exploration

Procedure: AppendectomyDiagnostic Test: blood sampling

Interventions

AppendectomyPROCEDURE

Appendectomy (Laparoscopic or conventional open surgery)

Also known as: Laparoscopic Appendectomy, Conventional Open Appendectomy
Complicated acute appendicitis casesUncomplicated acute appendicitis cases
blood samplingDIAGNOSTIC_TEST

Blood samples, in the preoperative period, routinely collected from the patients of acute appendicitis cases

Complicated acute appendicitis casesUncomplicated acute appendicitis cases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients operated diagnosed as acute appendicitis.

You may qualify if:

  • Being over 18 years of age
  • Having undergone surgical treatment for a diagnosis of acute appendicitis (Laparoscopic or conventional open surgery)
  • Patients with no missing data in their records

You may not qualify if:

  • Patients under 18 years of age
  • Cases of uncomplicated acute appendicitis diagnosed but treated medically
  • Patients with incomplete data
  • Those with chronic kidney and liver failure
  • Patients with liver diseases such as Wilson's disease or alpha-1 antitrypsin deficiency
  • Individuals with hematological malignancies like ALL or AML
  • Patients with genetic bleeding disorders such as hemophilia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location

Related Publications (9)

  • Kirkil C, Karabulut K, Aygen E, Ilhan YS, Yur M, Binnetoglu K, Bulbuller N. Appendicitis scores may be useful in reducing the costs of treatment for right lower quadrant pain. Ulus Travma Acil Cerrahi Derg. 2013 Jan;19(1):13-9. doi: 10.5505/tjtes.2013.88714.

    PMID: 23588973BACKGROUND
  • Kirkil C, Yigit MV, Aygen E. Long-term results of nonoperative treatment for uncomplicated acute appendicitis. Turk J Gastroenterol. 2014 Aug;25(4):393-7. doi: 10.5152/tjg.2014.7192.

    PMID: 25254521BACKGROUND
  • Bozan MB, Yazar FM, Boran OF, Guler O, Azak Bozan A. Are the immature granulocyte count and percentage important in continue medical treatment in acute appendicitis? A prospective, randomized, and controlled study. Ulus Travma Acil Cerrahi Derg. 2022 Jul;28(7):979-987. doi: 10.14744/tjtes.2021.76307.

    PMID: 35775679BACKGROUND
  • Guler O, Bozan MB, Alkan Baylan F, Oter S. The Utility of Immature Granulocyte Count and Percentage on the Prediction of Acute Appendicitis in the Suspected Acute Appendicitis According to the Alvarado Scoring System: A Retrospective Cohort Study. Turk J Gastroenterol. 2022 Oct;33(10):891-898. doi: 10.5152/tjg.2022.21865.

    PMID: 35946881BACKGROUND
  • Zhang Y, Zhao YY, Qiao J, Ye RH. Diagnosis of appendicitis during pregnancy and perinatal outcome in the late pregnancy. Chin Med J (Engl). 2009 Mar 5;122(5):521-4.

    PMID: 19323901BACKGROUND
  • Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. Am J Epidemiol. 1990 Nov;132(5):910-25. doi: 10.1093/oxfordjournals.aje.a115734.

    PMID: 2239906BACKGROUND
  • Khanapure S, Nagral S, Nanavati AJ. A study of events between the onset of symptoms and hospital admission in patients with acute abdomen. Natl Med J India. 2017 Mar-Apr;30(2):65-68.

    PMID: 28816211BACKGROUND
  • Bokemeyer A, Ochs K, Fuhrmann V. [Acute Abdomen: Diagnostic Management]. Dtsch Med Wochenschr. 2020 Oct;145(21):1544-1551. doi: 10.1055/a-1007-4264. Epub 2020 Oct 20. German.

    PMID: 33080641BACKGROUND
  • Ag O, Kutluer N, Ogut MZ, Azak Bozan A, Ebiloglu MF, Gunes B, Ayyildiz H, Bozan MB. The Importance of Preoperatively Calculated Halp Score in Differentiating Complicated Acute Appendicitis in Patients With Acute Appendicitis. World J Surg. 2026 Jan;50(1):121-129. doi: 10.1002/wjs.70160. Epub 2025 Nov 25.

MeSH Terms

Conditions

Appendicitis

Interventions

AppendectomyBlood Specimen Collection

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Associate

Study Record Dates

First Submitted

May 25, 2025

First Posted

June 3, 2025

Study Start

January 1, 2020

Primary Completion

January 1, 2025

Study Completion

May 20, 2025

Last Updated

June 26, 2025

Record last verified: 2025-06

Locations