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Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Sand, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT00677417
First received: May 12, 2008
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
Perforated Appendicitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Retrospective Study Investigating the Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ruhr University of Bochum:

Enrollment: 538
Study Start Date: May 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

We identified 538 patients with histologically proved acute appendicitis who underwent laparoscopic or conventional appendicectomy between January, 2004 and December, 2007 in a surgical department of an academic teaching hospital. A retrospective multiple chart review of the medical records including laboratory values (bilirubin, CRP, white blood count) and histological results was conducted.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677417

Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: 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
  More Information

Publications:

Responsible Party: Michael Sand, Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT00677417     History of Changes
Other Study ID Numbers: 001
Study First Received: May 12, 2008
Last Updated: October 15, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Hyperbilirubinemia
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013