NCT00528138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

November 10, 2009

Status Verified

November 1, 2009

Enrollment Period

11 months

First QC Date

September 10, 2007

Last Update Submit

November 9, 2009

Conditions

Perforated Appendicitis

Keywords

AppendicitisHyperbilirubinemiaCRPValues of bilirubinValues of liver function testValues of white blood cellsValues of CRP

Study Arms (2)

1

Simple appendicitis

Other: Laboratory Test

2

Perforated appendicitis

Other: Laboratory Test

Interventions

Laboratory TestOTHER

CRP, white blood cell count, hepatic function tests

12

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suspected of having acute appendicitis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital De La Serena - Emergency Unit

La Serena, Coquimbo Region, IV Region, Chile

Location

MeSH Terms

Conditions

AppendicitisHyperbilirubinemia

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Marcelo A Beltran, MD

    Hospital de La Serena

    PRINCIPAL INVESTIGATOR

  • Rodrigo Barrera, MD

    Hospital de La Serena

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 12, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 10, 2009

Record last verified: 2009-11

Locations

CL(1)