NCT06956638

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2025

Completed
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

April 24, 2025

Last Update Submit

May 3, 2025

Conditions

Keywords

Single-centerprospectivecross-sectional

Outcome Measures

Primary Outcomes (1)

  • Perforated appendix

    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

Study Arms (1)

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

Interventions

Non-interventional study

Patients of age group above 5 years with acute appendicitis undergoing appendectomy

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shree Birendra Hospital

Kathmandu, Bagmati, 44620, Nepal

Location

Related Publications (4)

  • Sirikurnpiboon S, Amornpornchareon S. Factors Associated with Perforated Appendicitis in Elderly Patients in a Tertiary Care Hospital. Surg Res Pract. 2015;2015:847681. doi: 10.1155/2015/847681. Epub 2015 Aug 24.

  • Potey K, Kandi A, Jadhav S, Gowda V. Study of outcomes of perforated appendicitis in adults: a prospective cohort study. Ann Med Surg (Lond). 2023 Mar 16;85(4):694-700. doi: 10.1097/MS9.0000000000000277. eCollection 2023 Apr.

  • Chaudhary P, Kumar A, Saxena N, Biswal UC. Hyperbilirubinemia as a predictor of gangrenous/perforated appendicitis: a prospective study. Ann Gastroenterol. 2013;26(4):325-331.

  • Sand M, Bechara FG, Holland-Letz T, Sand D, Mehnert G, Mann B. Diagnostic value of hyperbilirubinemia as a predictive factor for appendiceal perforation in acute appendicitis. Am J Surg. 2009 Aug;198(2):193-8. doi: 10.1016/j.amjsurg.2008.08.026. Epub 2009 Mar 23.

Related Links

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Bhairav Kumar Hamal, MS, Fellow - Urosurgery

    Nepalese Army Institute of Health Sciences

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 4, 2025

Study Start

July 16, 2022

Primary Completion

June 15, 2023

Study Completion

March 12, 2025

Last Updated

May 7, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

All collected IPD

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations