NCT01698099

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

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, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed
Last Updated

October 2, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

September 24, 2012

Last Update Submit

September 27, 2012

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age16 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing appendectomy for suspected appendicitis

You may qualify if:

  • all patients undergoing appendectomy for suspected appendicitis

You may not qualify if:

  • preexisting liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Visceral- and Transplant Surgery, University of Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (1)

  • Muller S, Falch C, Axt S, Wilhelm P, Hein D, Konigsrainer A, Kirschniak A. Diagnostic accuracy of hyperbilirubinaemia in anticipating appendicitis and its severity. Emerg Med J. 2015 Sep;32(9):698-702. doi: 10.1136/emermed-2013-203349. Epub 2014 Dec 4.

    PMID: 25476715DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Sven Müller, MD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2012

First Posted

October 2, 2012

Study Start

May 1, 2009

Primary Completion

August 1, 2011

Study Completion

September 1, 2012

Last Updated

October 2, 2012

Record last verified: 2012-09

Locations

DE(1)