Appendicitis, SurgeryNCT07291882
Serum Hyperbilirubinemia as an Early Predictive Factor for Complicated Appendicitis: Single Center Experience
An observational study of Appendicitis, Surgery, run by Minia University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Appendicitis, Surgery
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 20 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients presenting with acute appendicitis at the Minia university hospital
Who may be able to join
- All patients presented with right iliac fossa pain diagnosed clinically as acute appendicitis and had undergone appendectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Appendicitis, Surgery
- Being tested
- Appendectomy
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Simple appendicitis ( group A) | Patients where no perforation, gangrene, or other complications were found during surgery. Receives: Procedure: Appendectomy | |
| 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. Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of serum total bilirubin in each case of appendicitis to clarify the relationship between serum hyperbilirubinemia and complicated appendicitis
Measured: between September 2024 and August 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Sep 2024
- Primary completion10 Sep 2024
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis, SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asaad AbdelRahman AbdelAziz Ahmad, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291882
- Sponsor's protocol ID
- Serum Hyperbilirubinemia
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Hyperbilirubinemia as an Early Predictive Factor for Complicated Appendicitis: Single Center Experience
- ClinicalTrials.gov ID
- NCT07291882
- Acronym / sponsor ID
- Serum Hyperbilirubinemia
- Conditions
- Appendicitis, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple appendicitis ( group A) | – | Procedure: AppendectomyPatients where no perforation, gangrene, or other complications were found during surgery. |
| Complicated appendicitis (group B) | – | Procedure: Appendectomy• 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presenting with acute appendicitis at the Minia university hospital
Key inclusion criteria (1 listed)
- All patients presented with right iliac fossa pain diagnosed clinically as acute appendicitis and had undergone appendectomy
Key exclusion criteria (6 listed)
- patients with past history of jaundice
- patients with history of hyperbilirubinemia hemolytic disease
- positive hepatitis viruses
- cholelithiasis
- acquired or congenital biliary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AppendectomyTotal 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. | Procedure or surgery | Complicated appendicitis (group B), Simple appendicitis ( group A) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, Surgery, run by Minia University at 1 site in Egypt.
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 1 inclusion and 6 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 29 Dec 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 Egypt. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.