Inflammatory Response in Appendicitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MARCELO A. BELTRAN, M.D., Cirujanos la Serena
ClinicalTrials.gov Identifier:
NCT01718171
First received: October 29, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition
Appendicitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Progression of the Systemic Inflammatory Response in Patients With Appendicitis

Resource links provided by NLM:


Further study details as provided by Cirujanos la Serena:

Primary Outcome Measures:
  • THE EXPECTED SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS [ Time Frame: 0 to more than 72 hours ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • THE ANALYSIS OF C REACTIVE PROTEIN TO MEASURE THE SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS [ Time Frame: from 0 to more than 72 hours ] [ Designated as safety issue: No ]
    Measurements of C-reactive protein levels


Enrollment: 183
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group I, Group II, Group III, Group IV
Values and results of the Systemic Inflammatory Response and C-reactive protein to appendicitis

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.
  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with appendicitis operated on and confirmed with biopsy

Criteria

Inclusion Criteria:

  • Patients with appendicitis

Exclusion Criteria:

  • Any patient with immunosuppressive or immunodeppressive known pathological conditions
  • Any patient with a pathological report describing a normal appendix
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718171

Locations
Chile
Hospital de La Serena (La Serena Hospital)
La Serena, IV Region, Chile, 17000000
Sponsors and Collaborators
Cirujanos la Serena
Investigators
Principal Investigator: Marcelo A Beltran, M.D. La Serena Hospital
  More Information

No publications provided

Responsible Party: MARCELO A. BELTRAN, M.D., DIGESTIVE SURGEON, Cirujanos la Serena
ClinicalTrials.gov Identifier: NCT01718171     History of Changes
Other Study ID Numbers: HLS-0044-2012
Study First Received: October 29, 2012
Last Updated: October 29, 2012
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by Cirujanos la Serena:
Appendicitis
SIRS
C-reactive protein

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014