AppendicitisdCRPappendNCT02730585
Diagnostic Performance of C Reactive Protein and Delta CRP in Acute Appendicitis
An observational study of Appendicitis, run by University of Monastir at 1 site in Tunisia.
Trial summary
The diagnosis of acute appendicitis is difficult and despite important advances in medical sciences, detailed patient questioning and precise medical examination are the main keystones of the diagnosis of acute appendicitis and up to now, results still unsatisfactory. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- C-reactive protein measurement
- How many people
- 500 participants
- Where
- 1 siteTunisia
- Study dates
- Jan 2010to Dec 2013
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients presenting to the Fattouma Bourguiba University hospital with an equivocal diagnosis of acute appendicitis. The clinical suspiscion of appendicitis was made based on anamnestic and physical examination findings.
Who may be able to join
- age > 8 year old
- clinical suspicion of acute appendicitis including the presence of direct tenderness in the right lower quadrant, percussion and rebound tenderness, pyrexia, anorexia, nausea and vomiting.
Who cannot join
- patients receiving anti coagulants
- pregnant women
- patients using antibiotics during the study period.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Emergency department of university hospital Fattouma Bourguiba of Monastir
Monastir, 5000
About this study
Official title: Evaluation of the Performance of C-reactive Protein (CRP) Concentrations Variation (Delta CRP) in the Diagnosis of Acute Appendicitis in the ER
The diagnosis of acute appendicitis is difficult and despite important advances in medical sciences, detailed patient questioning and precise medical examination are the main keystones of the diagnosis of acute appendicitis and up to now, results still unsatisfactory.
Read the detailed description
Acute appendicitis is the most common surgical emergency and the most common source of community-acquired intra-abdominal infections. The lack of accuracy in the diagnosis of acute appendicitis yields often to two types of outcomes: a delay in diagnosis leads to perforation and peritonitis in up to 15% of the cases and unnecessary appendectomy is associated with post-operative complications such as wound infection and adhesions. CRP is an acute phase protein that is often used by many surgeons as a diagnostic marker of acute appendicitis. During the evaluation of patients with possible appendicitis in the emergency department (ED), repeated physical examination of the abdomen may provide further information about the decision making. However, the role of repeated laboratory examinations is not proven.
The purpose of this study was to investigate whether repeated serum CRP measures could be useful to predict acute appendicitis, after 3 hours of observation, in comparison with the histopathological findings.
- Conditions
- Appendicitis
- Being tested
- C-reactive protein measurement
- Keywords
- 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.
C-reactive protein measurementBiological
All patients included in this study underwent a blood sample analysis for C-reactive protein concentrations at admission and 3 hours later.
| Study group | Role | What they receive |
|---|---|---|
| Acute appendicitis | all patients admitted to our hospital with a clinically suspected acute appendicitis. Receives: Biological: C-reactive protein measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final diagnosis of acute appendicitis
The final diagnosis of acute appendicitis was based, in operated patients, on the results of the histologic examination of the excised appendix and, in non operated patients, on the absence of acute appendicitis at the 2 weeks follow-up visit.
Measured: 15 days from patients inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Semir, Professor, Principal investigator, University Hospital of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730585
- Sponsor's protocol ID
- 04/2016
- Acronym
- dCRPappend
- Status last verified
- Aug 2016
- First submitted
- 1 Apr 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hallan S, Asberg A. The accuracy of C-reactive protein in diagnosing acute appendicitis--a meta-analysis. Scand J Clin Lab Invest. 1997 Aug;57(5):373-80. doi: 10.3109/00365519709084584.
PubMed 9279962Davies AH, Bernau F, Salisbury A, Souter RG. C-reactive protein in right iliac fossa pain. J R Coll Surg Edinb. 1991 Aug;36(4):242-4.
PubMed 1941740Paajanen H, Mansikka A, Laato M, Ristamaki R, Pulkki K, Kostiainen S. Novel serum inflammatory markers in acute appendicitis. Scand J Clin Lab Invest. 2002;62(8):579-84. doi: 10.1080/003655102764654312.
PubMed 12564616
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of C-reactive Protein (CRP) Concentrations Variation (Delta CRP) in the Diagnosis of Acute Appendicitis in the ER
- ClinicalTrials.gov ID
- NCT02730585
- Acronym / sponsor ID
- dCRPappend / 04/2016
- Conditions
- Appendicitis
- Keywords
- C-reactive protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Apr 2016 (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.
The diagnosis of acute appendicitis is difficult and despite important advances in medical sciences, detailed patient questioning and precise medical examination are the main keystones of the diagnosis of acute appendicitis and up to now, results still unsatisfactory.
Detailed description
Acute appendicitis is the most common surgical emergency and the most common source of community-acquired intra-abdominal infections. The lack of accuracy in the diagnosis of acute appendicitis yields often to two types of outcomes: a delay in diagnosis leads to perforation and peritonitis in up to 15% of the cases and unnecessary appendectomy is associated with post-operative complications such as wound infection and adhesions. CRP is an acute phase protein that is often used by many surgeons as a diagnostic marker of acute appendicitis. During the evaluation of patients with possible appendicitis in the emergency department (ED), repeated physical examination of the abdomen may provide further information about the decision making. However, the role of repeated laboratory examinations is not proven.
The purpose of this study was to investigate whether repeated serum CRP measures could be useful to predict acute appendicitis, after 3 hours of observation, in comparison with the histopathological findings.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute appendicitis | – | Biological: C-reactive protein measurementall patients admitted to our hospital with a clinically suspected acute appendicitis. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presenting to the Fattouma Bourguiba University hospital with an equivocal diagnosis of acute appendicitis. The clinical suspiscion of appendicitis was made based on anamnestic and physical examination findings.
Key inclusion criteria (2 listed)
- age > 8 year old
- clinical suspicion of acute appendicitis including the presence of direct tenderness in the right lower quadrant, percussion and rebound tenderness, pyrexia, anorexia, nausea and vomiting.
Key exclusion criteria (3 listed)
- patients receiving anti coagulants
- pregnant women
- patients using antibiotics during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-reactive protein measurementAll patients included in this study underwent a blood sample analysis for C-reactive protein concentrations at admission and 3 hours later. | Biological | Acute appendicitis |
Primary outcome
Final diagnosis of acute appendicitis
Time frame: 15 days from patients inclusion
The final diagnosis of acute appendicitis was based, in operated patients, on the results of the histologic examination of the excised appendix and, in non operated patients, on the absence of acute appendicitis at the 2 weeks follow-up visit.
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 1 Sep 2016.
- Background: PubMed 9279962Hallan S, Asberg A. The accuracy of C-reactive protein in diagnosing acute appendicitis--a meta-analysis. Scand J Clin Lab Invest. 1997 Aug;57(5):373-80. doi: 10.3109/00365519709084584.
- Background: PubMed 1941740Davies AH, Bernau F, Salisbury A, Souter RG. C-reactive protein in right iliac fossa pain. J R Coll Surg Edinb. 1991 Aug;36(4):242-4.
- Background: PubMed 12564616Paajanen H, Mansikka A, Laato M, Ristamaki R, Pulkki K, Kostiainen S. Novel serum inflammatory markers in acute appendicitis. Scand J Clin Lab Invest. 2002;62(8):579-84. doi: 10.1080/003655102764654312.
- Individual participant dataSharing planned: Undecided
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
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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.
Nouira Semir, Professor principal investigator
University Hospital of Monastir
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 University of Monastir at 1 site in Tunisia.
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 2 inclusion and 3 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 1 Sep 2016. 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 Tunisia. 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?
Final diagnosis of acute appendicitis (time frame: 15 days from patients inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02730585, which also lists 3 linked publications.
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 1 Sep 2016.