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Acute AppendicitisAppendicitisNCT07002671

The Role of Preoperative HALP Score in Differentiating Complicated Acute Appendicitis

An observational study of Acute Appendicitis and Acute Appendicitis Without Peritonitis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Appendectomy and blood sampling
Type of treatment
Surgery or procedure
How many people
411 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2020to 20 May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients operated diagnosed as acute appendicitis.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Elazığ Fethi Sekin City Hospital

    Elâzığ, 23100

Other trials in Turkey (Türkiye)

About this study

Official title: The Significance of Preoperatively Calculated HALP Score in Differentiating Complicated Acute Appendicitis in Patients With Acute Appendicitis

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.

Read more

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.

Read the detailed description

*Aim of the Study Acute abdomen is a frequently encountered clinical condition that can be fatal if not diagnosed early. Numerous diseases can cause acute abdomen, making accurate and rapid diagnosis extremely important. Acute appendicitis is one of the causes of acute abdomen and is the most common clinical condition leading to acute abdomen worldwide.

In a study by Addiss et al., the incidence of acute appendicitis was approximately 233 per 100,000 people. Although slightly more common in males, there is a lifetime risk of about 7%.

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.

The reported incidence of complicated appendicitis and its complications in various studies ranges from approximately 20% to 30%. This significant rate increases the risk of morbidity and mortality. Thus, early diagnosis and treatment of appendicitis are of great importance to prevent the development of complications.

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.

Alongside laboratory and radiological findings, commonly used scoring systems are also available. Among these, the Alvarado scoring system, first described in 1986, is the most frequently used and popular system, and it remains the primary system consulted in patients with a preliminary diagnosis of acute appendicitis.

Beyond the Alvarado score, the Appendicitis Inflammatory Response (AIR) score, a more recently developed system, is also gaining widespread use. Furthermore, scoring systems created using artificial intelligence with current technologies have also been described.

In recent years, a new scoring system, the HALP score, was first developed by Chen et al. to predict the prognosis of gastric carcinomas. This score is calculated as [hemoglobin (g/L) × albumin (g/L) × lymphocytes (/L)] / platelets (/L).

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. Its use has become widespread because HALP is a scoring system composed of routinely used parameters, such as platelet and lymphocyte counts, albumin (indicating nutritional status), and hemoglobin (indicating anemic status).

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.

  • Material-Methods This study was planned as a retrospective study. For this purpose, it was planned to include patients who were diagnosed with acute appendicitis and operated on in Elazığ Fethi Sekin City Hospital General Surgery Clinic between 01.01.2020 and 01.01.2025. Complete blood count (CBC) and biochemistry values of the patients studied in the preoperative period were recorded by retrospective file scanning. Patients will be divided into two groups according to the postoperative pathology results and exploration findings by examining the pathology results and surgery notes recorded in the system, as complicated acute appendicitis (pathological diagnosis of gangrenous, phlegmonous, perforated or presence of perforation, abscess or plastron in surgical exploration) and uncomplicated acute appendicitis (pathological diagnosis of acute appendicitis). Preopartive HALP score levels will be compared between groups. Since the study is planned retrospectively, the sample size will not be calculated.
  • Data Collection Tools Patients' age, gender, complete blood count (CBC), biochemistry, and pathology data will be evaluated.
  • Statistical Analysis Data analysis will be performed using the IBM Statistical Analysis for Social Sciences (SPSS) ver 20 statistical software package. The Shapiro-Wilk test will be conducted to assess the normality of distribution for numerical data. Based on the normality of distribution, either the Student's t-test or the Mann-Whitney U test will be used. Numerical data will be presented as mean ± standard deviation (minimum - maximum values) or median (95% Confidence Interval), depending on their conformity to normal distribution.

For comparing categorical data, the Chi-square analysis or Fisher's exact test will be used. Categorical data will be presented as count (n) and percentage (%). Univariate analysis will be performed to identify factors effective in the preoperative prediction of complicated acute appendicitis, followed by multivariate analysis. A probability value of P<0.05 will be considered statistically significant.

Being tested
Appendectomy, blood sampling
Keywords
Acute Appendicitis, Complicated Acute Appendicitis, Uncomplicated Acute Appendicitis, HALP Score
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AppendectomyProcedure or surgery

    Also called Laparoscopic Appendectomy, Conventional Open Appendectomy

    Appendectomy (Laparoscopic or conventional open surgery)

  • blood samplingDiagnostic test

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

Study groups in NCT07002671
Study groupRoleWhat they receive
Complicated acute appendicitis casesAcute appendicitis cases with pathological diagnosis of gangrenous, phlegmonous, perforated or presence of perforation, abscess or plastron in surgical exploration
Receives: Procedure: Appendectomy; Diagnostic Test: blood sampling
Uncomplicated acute appendicitis casesAcute appendicitis cases without pathological diagnosis of gangrenous, phlegmonous, perforated or presence of perforation, abscess or plastron in surgical exploration
Receives: Procedure: Appendectomy; Diagnostic Test: blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2020,01,01-2025,01,01

Secondary outcomes (1)
  1. Preoperative cut off value levels of HALP score to determine complicated acute appendicitis

    Manually calculated preoperative HALP score from CBC results of acute appendicitis cases, it will be determined cut-off values according to ROC analysis for complicated acute appendicitis values.

    Measured: 2020,01,01-2025,01,01

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start1 Jan 2020
  3. Primary completion1 Jan 2025
  4. Study completion20 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
411 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002671
Sponsor's protocol ID
2025/9-8
Acronym
Appendicitis
Status last verified
Jun 2025
First submitted
25 May 2025
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23588973
  • 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.

    PubMed 25254521
  • 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.

    PubMed 35775679
  • 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.

    PubMed 35946881
  • 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.

    PubMed 19323901
  • 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.

    PubMed 2239906
  • 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.

    PubMed 28816211
  • 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.

    PubMed 33080641
  • 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.

    PubMed 41291390

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Appendicitis and Acute Appendicitis Without Peritonitis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preoperative HALP Score (time frame: 2020,01,01-2025,01,01). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07002671, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.

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