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Diagnostic Accuracy of Serum Bilirubin in the Prediction of Perforated Appendicitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sven Mueller, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01698099
First received: September 24, 2012
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

Hyperbilirubinemia is reported to be a positive predictor in diagnosing perforated appendicitis. Therefore we analysed the diagnostic accuracy of serum bilirubin in discriminating between perforated and simple/no appendicitis.

Methods:

All consecutive patients undergoing appendectomy for suspected appendicitis from May 2009 to August 2011 were analysed. Primary endpoint was the diagnostic accuracy of serum bilirubin levels to detect perforated appendicitis.


Condition
Appendicitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Diagnostic Accuracy of Serum Bilirubin in the Prediction of Perforated Appendicitis

Resource links provided by NLM:

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Diagnostic accuracy of serum bilirubin [ Time Frame: 24h within initial presentation with clinical symptoms ] [ Designated as safety issue: No ]
    assessment of the diagnostic accuracy of hyperbilirubinemia (defined as serum bilirubin above 1.1 md/dl)


Enrollment: 500
Study Start Date: May 2009
Study Completion Date: September 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients undergoing appendectomy for suspected appendicitis

Criteria

Inclusion Criteria:

  • all patients undergoing appendectomy for suspected appendicitis

Exclusion Criteria:

  • preexisting liver disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698099

Locations
Germany
Departement of Visceral- and Transplant Surgery, University of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Sven Müller, MD University Hospital Tuebingen
  More Information

No publications provided

Responsible Party: Sven Mueller, Principal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01698099     History of Changes
Other Study ID Numbers: APP001
Study First Received: September 24, 2012
Last Updated: September 27, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
 Pathologic Processes
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013