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CompletedNCT01718171Updated Oct 31, 2012

Inflammatory Response in Appendicitis

An observational study in Appendicitis, sponsored by Cirujanos la Serena. Completed at 1 site in Chile. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-10-31.

Sponsored by Cirujanos la Serena · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
183
Ages
15 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description
  • A prospective non-interventional, observational, descriptive study was conducted.
  • At our institution a median of 250 adult patients are submitted to emergency appendectomy every year. From this universe, a sample of 152 patients with a power of 80%, an error of 5% and 95% Confidence Intervals was required to perform this study.
  • We included 268 patients in the database, of them 85 cases that did not comply with the inclusion criteria were excluded from the analysis. A total of 183 patients (100%) selected according to the following criteria were studied: Patients with appendicitis confirmed by histology operated on our institutional Emergency Unit with an age range from 15 to 80 years.
  • Any patient with immunosuppressive or immunodeppressive known pathological conditions was excluded, as well as any patient with a pathological report describing a normal appendix.
  • Patients were divided into four groups according to the interval of time calculated from the onset of symptoms to diagnostic: Group I from 0 to 24 h, Group II from 25 to 48 h, Group III from 49 to 72 h and Group IV more than 73 h.
  • At admission demographic, clinical data, and the interval of time from the onset of symptoms to diagnostic was recorded, together with the White Blood Cell (WBC) count, C-reactive protein (CRP) values, and SIRS score.
  • The primary outcome measure was to determine the expected systemic inflammatory response to acute appendicitis according to established groups of time intervals from the onset of symptoms to diagnostic using the SIRS for that purpose.
  • The secondary outcome measure was the analysis of the CRP to measure the systemic inflammatory response, as another parameter which is habitually included within the diagnostic study of patients with suspected appendicitis.
02

Conditions studied

  • Appendicitis

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Keywords

  • Appendicitis
  • SIRS
  • C-reactive protein
03

In context

Appendicitis

412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.

This study's enrollment of 183 is close to the median of 200 across 150 observational studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Cirujanos la Serena is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with appendicitis operated on and confirmed with biopsy

Inclusion criteria

  • Patients with appendicitis

Exclusion criteria

Exclusion Criteria:

  • Any patient with immunosuppressive or immunodeppressive known pathological conditions
  • Any patient with a pathological report describing a normal appendix
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
183 participants (actual)

Groups and cohorts

  • Group I, Group II, Group III, Group IV

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

06

What researchers measure

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

    Time frame: 0 to more than 72 hours

Secondary outcomes

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

    Measurements of C-reactive protein levels

    Time frame: from 0 to more than 72 hours

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Study locations

1 site
  • Hospital de La Serena (La Serena Hospital)
    La Serena, IV Region 17000000, Chile
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01718171
Lead sponsor
Cirujanos la Serena
Responsible party
MARCELO A. BELTRAN, M.D. (DIGESTIVE SURGEON, Cirujanos la Serena) — Principal investigator
First posted
Oct 31, 2012
Start date
Jan 2011
Primary completion
Jan 2012
Completion
Jul 2012
Last update
Oct 31, 2012

Study contacts

Marcelo A Beltran, M.D.
principal investigator · La Serena Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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