AppendicitisNCT01698099
Diagnostic Accuracy of Serum Bilirubin in the Prediction of Perforated Appendicitis
An observational study of Appendicitis, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 16 to 95 years
- Conditions the study is for
- Appendicitis
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients undergoing appendectomy for suspected appendicitis
Who may be able to join
- all patients undergoing appendectomy for suspected appendicitis
Who cannot join
- preexisting liver disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Departement of Visceral- and Transplant Surgery, University of Tuebingen
Tübingen, 72076
About this study
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.
- Conditions
- Appendicitis
- Medical subject headings
- Appendicitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of serum bilirubin
assessment of the diagnostic accuracy of hyperbilirubinemia (defined as serum bilirubin above 1.1 md/dl)
Measured: 24h within initial presentation with clinical symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startMay 2009
- Primary completionAug 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Mueller, University Hospital Tuebingen
- Investigators
- Sven Müller, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698099
- Sponsor's protocol ID
- APP001
- Status last verified
- Sep 2012
- First submitted
- 24 Sep 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25476715
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Serum Bilirubin in the Prediction of Perforated Appendicitis
- ClinicalTrials.gov ID
- NCT01698099
- Acronym / sponsor ID
- APP001
- Conditions
- Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing appendectomy for suspected appendicitis
Key inclusion criteria (1 listed)
- all patients undergoing appendectomy for suspected appendicitis
Key exclusion criteria (1 listed)
- preexisting liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of serum bilirubin
Time frame: 24h within initial presentation with clinical symptoms
assessment of the diagnostic accuracy of hyperbilirubinemia (defined as serum bilirubin above 1.1 md/dl)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Derived from this study: PubMed 25476715Muller 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.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Müller, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of serum bilirubin (time frame: 24h within initial presentation with clinical symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01698099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.