NCT00674726

Brief Summary

The investigators are studying prospectively the difference in axilo-rectal temperature in patients with acute appendicitis and using as a control group patients consulting with acute gastroenteritis at our emergency unit.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

Study Start

First participant enrolled

May 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

Same day

First QC Date

May 6, 2008

Last Update Submit

October 29, 2012

Conditions

AppendicitisGastroenteritis

Keywords

appendicitisgastroenteritistemperaturefeveracute abdomenAxilo-rectal temperature in appendicitisAxilo-rectal temperature in gastroenteritis

Outcome Measures

Primary Outcomes (1)

  • The real difference in axilo-rectal temperature in patients with acute appendicitis

    6 hours

Secondary Outcomes (1)

  • The differences in axilo-rectal temperature between patients with acute appendicitis and acute gastroenteritis

    6 hours

Study Arms (2)

Group I

Patients with acute appendicitis

Other: Observation and measurement of axilo-rectal temperature

Group II

Patients with acute gastroenteritis

Other: Observation and measurement of axilo-rectal temperature

Interventions

Observation and measurement of axilo-rectal temperatureOTHER

Measurement of axilo-rectal temperature

Group IGroup II

Eligibility Criteria

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

Patients consulting in the emergency unit with acute appendicitis or acute gastroenteritis

You may qualify if:

  • Patients with acute appendicitis
  • Patients with acute gastroenteritis
  • Patients older than 15 years of age

You may not qualify if:

  • Other acute abdominal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de La Serena - Emergency Unit

La Serena, Coquimbo Region, Chile

Location

Hospital de La Serena

La Serena, Coquimbo Region, Chile

Location

MeSH Terms

Conditions

AppendicitisGastroenteritisFeverAbdomen, Acute

Interventions

Observation

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsAbdominal PainPainNeurologic ManifestationsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Marcelo A Beltran, M.D.

    Hospital de La Serena

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DIGESTIVE SURGEON

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 8, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

CL(2)