NCT00677417

Brief Summary

The values of laboratory examinations which are useful for the diagnoses of appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation rate (ESR). However up to date there is no laboratory marker for the pre-operative diagnosis of appendiceal perforation in acute appendicitis. Recently hyperbilirubinaemia has been associated with appendiceal perforation. Aim of this retrospective study is therefore to investigate if hyperbilirubinaemia has a diagnostic value for the pre-operative diagnosis of appendiceal perforation in patients with appendicitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
538

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

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

May 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

Enrollment Period

Same day

First QC Date

May 12, 2008

Last Update Submit

October 15, 2012

Conditions

Eligibility Criteria

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

Patients who are appendectomied and who received preoperative Liver function test (bilirubin, liver transaminases GOT and GPT)

You may qualify if:

  • Appendicitis and a preoperative laboratory workup with Leukocytes, C-reactive Protein, Bilirubin and liver transaminases GOT and GPT

You may not qualify if:

  • Alcoholism
  • A history of viral hepatitis
  • Gilbert's disease
  • Dubin Johnson syndrome
  • BRIC (benign recurrent intra-hepatic cholestasis) and other documented biliary
  • Hemolytic or liver diseases associated with hyperbilirubinaemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Benno Mann, PD Dr. med.

    Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany

    PRINCIPAL INVESTIGATOR
  • Michael Sand, Dr. med.

    Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 16, 2012

Record last verified: 2012-10