Perforated AppendicitisNCT00677417
Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis
An observational study of Perforated Appendicitis, run by Ruhr University of Bochum.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perforated Appendicitis
- How many people
- 538 participants
- Where
- No sites listed yet
- Study dates
- May 2008to May 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are appendectomied and who received preoperative Liver function test (bilirubin, liver transaminases GOT and GPT)
Who may be able to join
- Appendicitis and a preoperative laboratory workup with Leukocytes, C-reactive Protein, Bilirubin and liver transaminases GOT and GPT
Who cannot join
- 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.
About this study
Official title: A Retrospective Study Investigating the Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis
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.
Read the 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.
- Conditions
- Perforated Appendicitis
- Medical subject headings
- Appendicitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2008
- Study completionMay 2008
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 Perforated AppendicitisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sand, Ruhr University of Bochum
- Investigators
- Benno Mann, PD Dr. med., Principal investigator, Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, GermanyMichael Sand, Dr. med., Principal investigator, Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677417
- Sponsor's protocol ID
- 001
- Status last verified
- Oct 2012
- First submitted
- 12 May 2008
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sand M, Bechara FG, Holland-Letz T, Sand D, Mehnert G, Mann B. Diagnostic value of hyperbilirubinemia as a predictive factor for appendiceal perforation in acute appendicitis. Am J Surg. 2009 Aug;198(2):193-8. doi: 10.1016/j.amjsurg.2008.08.026. Epub 2009 Mar 23.
PubMed 19306980
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Investigating the Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis
- ClinicalTrials.gov ID
- NCT00677417
- Acronym / sponsor ID
- 001
- Conditions
- Perforated Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 14 May 2008 (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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are appendectomied and who received preoperative Liver function test (bilirubin, liver transaminases GOT and GPT)
Key inclusion criteria (1 listed)
- Appendicitis and a preoperative laboratory workup with Leukocytes, C-reactive Protein, Bilirubin and liver transaminases GOT and GPT
Key exclusion criteria (6 listed)
- Alcoholism
- A history of viral hepatitis
- Gilbert's disease
- Dubin Johnson syndrome
- BRIC (benign recurrent intra-hepatic cholestasis) and other documented biliary
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
Not reported in the source record.
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 16 Oct 2012.
- Results publication: PubMed 19306980Sand M, Bechara FG, Holland-Letz T, Sand D, Mehnert G, Mann B. Diagnostic value of hyperbilirubinemia as a predictive factor for appendiceal perforation in acute appendicitis. Am J Surg. 2009 Aug;198(2):193-8. doi: 10.1016/j.amjsurg.2008.08.026. Epub 2009 Mar 23.
Related trials for Perforated Appendicitis
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Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
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Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
Perforated Appendicitis
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Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
Appendicitis With Perforation, Appendectomy
Active, not recruitingPhase 2
Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
Perforated Appendicitis
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.
Benno Mann, PD Dr. med. principal investigator
Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany
Michael Sand, Dr. med. principal investigator
Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Perforated Appendicitis, run by Ruhr University of Bochum.
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 6 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 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00677417, 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 16 Oct 2012.