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Hyperbilirubinemia in Acute Appendicitis as a Predictor of Perforation

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ClinicalTrials.gov Identifier: NCT00528138
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : November 10, 2009
Sponsor:
Information provided by:
Cirujanos la Serena

Brief 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, 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.


Condition or disease Intervention/treatment
Perforated Appendicitis Other: Laboratory Test

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 Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Comparing Hyperbilirubinemia, CRP, White Blood Cell Count, and Other Clinical Parameters for the Preoperative Diagnosis of Perforated Acute Appendicitis
Study Start Date : October 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1
Simple appendicitis
Other: Laboratory Test
CRP, white blood cell count, hepatic function tests

2
Perforated appendicitis
Other: Laboratory Test
CRP, white blood cell count, hepatic function tests





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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suspected of having acute appendicitis
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528138


Locations
Chile
Hospital De La Serena - Emergency Unit
La Serena, IV Region, Chile, IV Region
Sponsors and Collaborators
Cirujanos la Serena
Investigators
Principal Investigator: Marcelo A Beltran, MD Hospital De La Serena
Study Director: Rodrigo Barrera, MD Hospital De La Serena

Additional Information:
Responsible Party: Marcelo A. Beltran, Hospital De La Serena
ClinicalTrials.gov Identifier: NCT00528138     History of Changes
Other Study ID Numbers: HLS-0045-07-07
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Cirujanos la Serena:
Appendicitis
Hyperbilirubinemia
CRP
Values of bilirubin
Values of liver function test
Values of white blood cells
Values of CRP

Additional relevant MeSH terms:
Appendicitis
Hyperbilirubinemia
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Pathologic Processes