Diagnostic Accuracy of Serum Bilirubin in the Prediction of Perforated Appendicitis

Appendicitis Clinical Trial

Official title:

Diagnostic Accuracy of Serum Bilirubin in the Prediction of Perforated Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698099
• Other study ID #: APP001
• Status: Completed
• Phase: N/A
• First received: September 24, 2012
• Last updated: September 27, 2012
• Start date: May 2009
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 95 Years

Eligibility

Inclusion Criteria:

• all patients undergoing appendectomy for suspected appendicitis

Exclusion Criteria:

• preexisting liver disease

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Appendicitis

Locations

Country	Name	City	State
Germany	Departement of Visceral- and Transplant Surgery, University of Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of serum bilirubin	assessment of the diagnostic accuracy of hyperbilirubinemia (defined as serum bilirubin above 1.1 md/dl)	24h within initial presentation with clinical symptoms	No