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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00677417
First Posted: May 14, 2008
Last Update Posted: October 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Sand, Ruhr University of Bochum
  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:


Further study details as provided by Michael Sand, 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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 12, 2008
First Posted: May 14, 2008
Last Update Posted: October 16, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Appendicitis
Hyperbilirubinemia
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Pathologic Processes