Perforated AppendicitisNCT00528138
Hyperbilirubinemia in Acute Appendicitis as a Predictor of Perforation
An observational study of Perforated Appendicitis, run by Cirujanos la Serena at 1 site in Chile.
Trial summary
It has recently been published that hyperbilirubinemia is a reliable marker for the preoperative diagnosis of perforated acute appendicitis. The investigators believe, based on their own previous publications, that C-reactive protein (CRP) with or without a white blood cell count and some other clinical parameters… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Perforated Appendicitis
- What is being tested?
- Laboratory Test
- How many people
- 132 participants
- Where
- 1 siteChile
- Study dates
- Oct 2007to Sep 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suspected of having acute appendicitis
Who may be able to join
- Patients scheduled for appendectomies for acute appendicitis at the emergency unit of our institution
- Patients older than 15 years of age to 100 years of age
Who cannot join
- Appendectomy performed incidentally or for other indications
- Patients younger than 15 years of age
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital De La Serena - Emergency Unit
La Serena, Coquimbo Region, IV Region
About this study
Official title: Prospective Study Comparing Hyperbilirubinemia, CRP, White Blood Cell Count, and Other Clinical Parameters for the Preoperative Diagnosis of Perforated Acute Appendicitis
It has recently been published that hyperbilirubinemia is a reliable marker for the preoperative diagnosis of perforated acute appendicitis.
The investigators believe, based on their own previous publications, that C-reactive protein (CRP) with or without a white blood cell count and some other clinical parameters, are more specific markers for the preoperative diagnosis of perforated acute appendicitis.
The purpose of this study is to prospectively compare the specificity and sensitivity of hyperbilirubinemia CRP, white blood cell count and other clinical parameters for the preoperative diagnosis of acute appendicitis.
Read the detailed description
- Previously validated appendicitis score
- Time from onset of symptoms to diagnosis and to surgery
- Laboratory values: WBC, CRP, liver function test
- SIRS values
- Preoperative and postoperative diagnosis
- Length of hospital stay
- Postoperative complications
- Biopsy results
- Conditions
- Perforated Appendicitis
- Being tested
- Laboratory Test
- Keywords
- Appendicitis, Hyperbilirubinemia, CRP, Values of bilirubin, Values of liver function test, Values of white blood cells, Values of CRP
- Medical subject headings
- Appendicitis, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory TestOther
CRP, white blood cell count, hepatic function tests
| Study group | Role | What they receive |
|---|---|---|
| 1 | Simple appendicitis Receives: Other: Laboratory Test | |
| 2 | Perforated appendicitis Receives: Other: Laboratory Test |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cirujanos la Serena
- Sponsor type
- University, hospital or other
- Investigators
- Marcelo A Beltran, MD, Principal investigator, Hospital de La SerenaRodrigo Barrera, MD, Study director, Hospital de La Serena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528138
- Sponsor's protocol ID
- HLS-0045-07-07
- Status last verified
- Nov 2009
- First submitted
- 10 Sep 2007
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Comparing Hyperbilirubinemia, CRP, White Blood Cell Count, and Other Clinical Parameters for the Preoperative Diagnosis of Perforated Acute Appendicitis
- ClinicalTrials.gov ID
- NCT00528138
- Acronym / sponsor ID
- HLS-0045-07-07
- Conditions
- Perforated Appendicitis
- Keywords
- Appendicitis, Hyperbilirubinemia, CRP, Values of bilirubin, Values of liver function test, Values of white blood cells, Values of CRP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Cirujanos la SerenaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 12 Sep 2007 (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.
It has recently been published that hyperbilirubinemia is a reliable marker for the preoperative diagnosis of perforated acute appendicitis.
The investigators believe, based on their own previous publications, that C-reactive protein (CRP) with or without a white blood cell count and some other clinical parameters, are more specific markers for the preoperative diagnosis of perforated acute appendicitis.
The purpose of this study is to prospectively compare the specificity and sensitivity of hyperbilirubinemia CRP, white blood cell count and other clinical parameters for the preoperative diagnosis of acute appendicitis.
Detailed description
- Previously validated appendicitis score
- Time from onset of symptoms to diagnosis and to surgery
- Laboratory values: WBC, CRP, liver function test
- SIRS values
- Preoperative and postoperative diagnosis
- Length of hospital stay
- Postoperative complications
- Biopsy results
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Laboratory TestSimple appendicitis |
| 2 | – | Other: Laboratory TestPerforated appendicitis |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suspected of having acute appendicitis
Key inclusion criteria (2 listed)
- Patients scheduled for appendectomies for acute appendicitis at the emergency unit of our institution
- Patients older than 15 years of age to 100 years of age
Key exclusion criteria (8 listed)
- Appendectomy performed incidentally or for other indications
- Patients younger than 15 years of age
- Alcoholism
- A history of viral hepatitis
- Gilbert's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory TestCRP, white blood cell count, hepatic function tests | Other | 1, 2 |
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 10 Nov 2009.
Related trials for Perforated Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
Not yet recruiting
Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
Perforated Appendicitis
Active, not recruiting
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.
Marcelo A Beltran, MD principal investigator
Hospital de La Serena
Rodrigo Barrera, MD study director
Hospital de La Serena
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 Perforated Appendicitis, run by Cirujanos la Serena at 1 site in Chile.
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 2 inclusion and 8 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 10 Nov 2009. 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 Chile. 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.
Where can I read the original study information?
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 10 Nov 2009.