- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07291882
Serum Hyperbilirubinemia as an Early Predictive Factor for Complicated Appendicitis: Single Center Experience
December 20, 2025 updated by: Asaad AbdelRahman AbdelAziz Ahmad, Minia University
Serum total bilirubin provides a practical guide to early assessment of suspected appendicitis, supporting faster and more proportionate decisions-earlier escalation when overall risk is high and safe observation when it is low.
Because testing is rapid, inexpensive, and universally available, integration into local diagnostic pathways is feasible.
Study Overview
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Minya, Egypt
- Minia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients presenting with acute appendicitis at the Minia university hospital
Description
Inclusion Criteria:
- All patients presented with right iliac fossa pain diagnosed clinically as acute appendicitis and had undergone appendectomy
Exclusion Criteria:
- patients with past history of jaundice
- patients with history of hyperbilirubinemia hemolytic disease
- positive hepatitis viruses
- cholelithiasis
- acquired or congenital biliary disease
- cancer of the hepatobiliary system
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Simple appendicitis ( group A)
Patients where no perforation, gangrene, or other complications were found during surgery.
|
Total bilirubin levels was measured preoperatively as part of the routine laboratory workup.
Appendectomy done for all patients followed by histopathological evaluation of the excised appendix.
|
|
Complicated appendicitis (group B)
• Complicated appendicitis group (B): Patients who presented with perforation or gangrene, confirmed via operative findings and histopathological examination. Total bilirubin levels was measured preoperatively as part of the routine laboratory workup. |
Total bilirubin levels was measured preoperatively as part of the routine laboratory workup.
Appendectomy done for all patients followed by histopathological evaluation of the excised appendix.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
measurement of serum total bilirubin in each case of appendicitis to clarify the relationship between serum hyperbilirubinemia and complicated appendicitis
Time Frame: between September 2024 and August 2025
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between September 2024 and August 2025
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2024
Primary Completion (Actual)
September 10, 2024
Study Completion (Actual)
August 20, 2025
Study Registration Dates
First Submitted
December 6, 2025
First Submitted That Met QC Criteria
December 6, 2025
First Posted (Estimated)
December 18, 2025
Study Record Updates
Last Update Posted (Actual)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 20, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Serum Hyperbilirubinemia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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