NCT01718171

Brief Summary

Although the presence of SIRS has been described in patients with appendicitis, its progressive response related and together with progression of symptomatology from the onset of symptoms to diagnostic has not been characterized. Continuation of the systemic inflammation in patients with injury and infectious processes may result in multiple organ dysfunction and ultimately failure. As with any acute inflammatory condition, the patients' systemic inflammatory response to appendicitis will progress and become more intense with the passing of time. The purpose of this study is to characterize the systemic inflammatory response to appendicitis from the beginning of symptoms to diagnostic in patients with appendicitis submitted to emergency surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

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

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

October 29, 2012

Last Update Submit

October 29, 2012

Conditions

Keywords

AppendicitisSIRSC-reactive protein

Outcome Measures

Primary Outcomes (1)

  • THE EXPECTED SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS

    Four groups of time intervals divided as follows: Group I: 0 - 24 hours Group II: 25 - 48 hours Group III: 49 - 72 hours Group IV: More than 73 hours

    0 to more than 72 hours

Secondary Outcomes (1)

  • THE ANALYSIS OF C REACTIVE PROTEIN TO MEASURE THE SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS

    from 0 to more than 72 hours

Study Arms (1)

Group I, Group II, Group III, Group IV

Values and results of the Systemic Inflammatory Response and C-reactive protein to appendicitis

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with appendicitis operated on and confirmed with biopsy

You may qualify if:

  • Patients with appendicitis

You may not qualify if:

  • Any patient with immunosuppressive or immunodeppressive known pathological conditions
  • Any patient with a pathological report describing a normal appendix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de La Serena (La Serena Hospital)

La Serena, Coquimbo Region, 17000000, Chile

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Marcelo A Beltran, M.D.

    La Serena Hospital

    PRINCIPAL INVESTIGATOR

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

October 29, 2012

First Posted

October 31, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

July 1, 2012

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations