Bilirubin Levels to Diagnose Appendicitis and Predict Appendiceal Perforation

May 3, 2025 updated by: Nepalese Army Institute of Health Sciences

Predictors of Appendiceal Perforation and the Role of Total Bilirubin at Presentation: A Single Center Prospective Cross-sectional Study in Nepal

The goal of this study is to learn if serum bilirubin levels can aid in the diagnosis of acute appendicitis and predict appendiceal perforation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study aims to assess hyperbilirubinemia: serum direct, indirect and total bilirubin to enhance the diagnostic accuracy of acute appendicitis. Also it aims to analyze different patient variables such as age, gender, duration of symptoms, leukocyte and neutrophil count, Alvarado score, presence of fever, nausea & vomiting, peritonitis alongside serum total bilirubin level in patients with appendicitis and assess which variables can be taken as independent factors to predict appendiceal perforation.

Study Type

Observational

Enrollment (Actual)

98

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

  • Nepal
    • Bagmati
      • Kathmandu, Bagmati, Nepal, 44620
        • Shree Birendra Hospital

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

Patients presenting with acute appendicitis at Shree Birendra Hospital, Chhauni, Kathmandu

Description

Inclusion Criteria:

  • Patients of age group above 5 years with acute appendicitis undergoing appendectomy with written informed consent.

Exclusion Criteria:

  • Patients with appendicular lump.
  • Patients with acute and chronic liver diseases like acute hepatitis, hemolytic disease, Gilbert's syndrome, Dubin-Johnson syndrome, alcoholic liver disease.
  • Acquired or Congenital Biliary Disease.
  • History of Hepatotoxic drugs.

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
Patients of age group above 5 years with acute appendicitis undergoing appendectomy
Patients of age group above 5 years with acute appendicitis undergoing appendectomy, without acute or chronic liver diseases, acquired or congenital bilirary diseases, history of use of hepatotoxic drugs or diagnosis of appendicular lump
Other: Non-interventional
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perforated appendix
Time Frame: Presentation to hospital till perioperative period
Perforated appendicitis was confirmed intraoperatively by the surgeon and at histological analysis of the specimen by the rupture of appendiceal wall to the serosa. Those with gangrenous walls were also taken as perforated.
Presentation to hospital till perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nepalese Army Institute of Health Sciences

Investigators

  • Study Chair: Bhairav Kumar Hamal, MS, Fellow - Urosurgery, Nepalese Army Institute of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

July 16, 2022

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

March 12, 2025

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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