Hyperbilirubinemia in Acute Appendicitis as a Predictor of Perforation

November 9, 2009 updated by: Cirujanos la Serena

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • IV Region
      • La Serena, IV Region, Chile, IV Region
        • Hospital De La Serena - Emergency Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suspected of having acute appendicitis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cirujanos la Serena

Investigators

  • Principal Investigator: Marcelo A Beltran, MD, Hospital de La Serena
  • Study Director: Rodrigo Barrera, MD, Hospital de La Serena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 10, 2007

First Submitted That Met QC Criteria

September 11, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 10, 2009

Last Update Submitted That Met QC Criteria

November 9, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLS-0045-07-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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