Inflammatory Response in Appendicitis
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|ClinicalTrials.gov Identifier: NCT01718171|
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : October 31, 2012
|Condition or disease|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||183 participants|
|Observational Model:||Case Control|
|Official Title:||Progression of the Systemic Inflammatory Response in Patients With Appendicitis|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||July 2012|
Group I, Group II, Group III, Group IV
Values and results of the Systemic Inflammatory Response and C-reactive protein to appendicitis
- THE EXPECTED SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS [ Time Frame: 0 to more than 72 hours ]
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
- THE ANALYSIS OF C REACTIVE PROTEIN TO MEASURE THE SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS [ Time Frame: from 0 to more than 72 hours ]Measurements of C-reactive protein levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718171
|Hospital de La Serena (La Serena Hospital)|
|La Serena, IV Region, Chile, 17000000|
|Principal Investigator:||Marcelo A Beltran, M.D.||La Serena Hospital|