NCT07291882

Brief 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. Because testing is rapid, inexpensive, and universally available, integration into local diagnostic pathways is feasible.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

9 days

First QC Date

December 6, 2025

Last Update Submit

December 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • measurement of serum total bilirubin in each case of appendicitis to clarify the relationship between serum hyperbilirubinemia and complicated appendicitis

    between September 2024 and August 2025

Study Arms (2)

Simple appendicitis ( group A)

Patients where no perforation, gangrene, or other complications were found during surgery.

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.

Procedure: Appendectomy

Interventions

AppendectomyPROCEDURE

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)Simple appendicitis ( group A)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presenting with acute appendicitis at the Minia university hospital

You may qualify if:

  • All patients presented with right iliac fossa pain diagnosed clinically as acute appendicitis and had undergone appendectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia university

Minya, Egypt

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and lecturer of general surgery

Study Record Dates

First Submitted

December 6, 2025

First Posted

December 18, 2025

Study Start

September 1, 2024

Primary Completion

September 10, 2024

Study Completion

August 20, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations