AppendicitisNCT01718171
Inflammatory Response in Appendicitis
An observational study of Appendicitis, run by Cirujanos la Serena at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Appendicitis
- How many people
- 183 participants
- Where
- 1 siteChile
- Study dates
- Jan 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with appendicitis operated on and confirmed with biopsy
Who may be able to join
- Patients with appendicitis
Who cannot join
- Any patient with immunosuppressive or immunodeppressive known pathological conditions
- Any patient with a pathological report describing a normal appendix
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital de La Serena (La Serena Hospital)
La Serena, Coquimbo Region, 17000000
About this study
Official title: Progression of the Systemic Inflammatory Response in Patients With Appendicitis
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.
- Conditions
- Appendicitis
- Keywords
- Appendicitis, SIRS, C-reactive protein
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I, Group II, Group III, Group IV | Values and results of the Systemic Inflammatory Response and C-reactive protein to appendicitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: from 0 to more than 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cirujanos la Serena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCELO A. BELTRAN, M.D., Cirujanos la Serena
- Investigators
- Marcelo A Beltran, M.D., Principal investigator, La Serena Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718171
- Sponsor's protocol ID
- HLS-0044-2012
- Status last verified
- Oct 2012
- First submitted
- 29 Oct 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of the Systemic Inflammatory Response in Patients With Appendicitis
- ClinicalTrials.gov ID
- NCT01718171
- Acronym / sponsor ID
- HLS-0044-2012
- Conditions
- Appendicitis
- Keywords
- Appendicitis, SIRS, C-reactive protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Cirujanos la SerenaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group I, Group II, Group III, Group IV | – | –Values and results of the Systemic Inflammatory Response and C-reactive protein to appendicitis |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with appendicitis operated on and confirmed with biopsy
Key inclusion criteria (1 listed)
- Patients with appendicitis
Key exclusion criteria (2 listed)
- Any patient with immunosuppressive or immunodeppressive known pathological conditions
- Any patient with a pathological report describing a normal appendix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
THE ANALYSIS OF C REACTIVE PROTEIN TO MEASURE THE SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS
Time frame: from 0 to more than 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo A Beltran, M.D. principal investigator
La Serena Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis, run by Cirujanos la Serena at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
THE EXPECTED SYSTEMIC INFLAMMATORY RESPONSE TO APPENDICITIS (time frame: 0 to more than 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012.