Acute AppendicitisNCT05116124
Inflammatory Parameters as Predictive Factors for Complicated Appendicitis
An observational study of Acute Appendicitis, run by Centro Hospitalar do Tâmega e Sousa.
Trial summary
Acute appendicitis is a major cause of acute abdomen. Although its diagnosis is clinical, it is often supported by complementary diagnostic tests. Sometimes, delay in diagnosis can lead to worsening of the clinical picture, resulting in a complicated acute appendicitis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- dosing of inflammatory parameters
- How many people
- 841 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2017
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted for acute appendicitis
Who may be able to join
- all patients admitted for acute appendicitis
Who cannot join
- excluded if no existence of dosing of all the inflammatory parameters cited above
About this study
Acute appendicitis is a major cause of acute abdomen. Although its diagnosis is clinical, it is often supported by complementary diagnostic tests. Sometimes, delay in diagnosis can lead to worsening of the clinical picture, resulting in a complicated acute appendicitis. Some series have studied some clinical and analytical parameters as possible predictors of complicated acute appendicitis.
A retrospective analysis of patients admitted for acute appendicitis and undergoing appendectomy between January 2014 and December 2017 was performed in order to assess the possible existence of preoperative analytical predictive factors for complicated acute appendicitis (such as leukocytosis, C-reactive protein and ratio between neutrophils and lymphocytes).
- Conditions
- Acute Appendicitis
- Being tested
- dosing of inflammatory parameters
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dosing of inflammatory parametersOther
View and register the dosing of inflammatory parameters
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - uncomplicated appendicitis | Not described Receives: Other: dosing of inflammatory parameters | |
| Group 2 - complicated appendicitis | Not described Receives: Other: dosing of inflammatory parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein dosage
Measured: 4 years
Leukocytosis dosage
Measured: 4 years
Ratio between neutrophils and lymphocytes dosage
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Jan 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 841 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Tâmega e Sousa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Ribeiro, Centro Hospitalar do Tâmega e Sousa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116124
- Sponsor's protocol ID
- CHR123456
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Parameters as Predictive Factors for Complicated Appendicitis
- ClinicalTrials.gov ID
- NCT05116124
- Acronym / sponsor ID
- CHR123456
- Conditions
- Acute Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 841 participants (actual)
- Lead sponsor
- Centro Hospitalar do Tâmega e SousaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 10 Nov 2021 (actual)
- 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.
Acute appendicitis is a major cause of acute abdomen. Although its diagnosis is clinical, it is often supported by complementary diagnostic tests. Sometimes, delay in diagnosis can lead to worsening of the clinical picture, resulting in a complicated acute appendicitis. Some series have studied some clinical and analytical parameters as possible predictors of complicated acute appendicitis.
A retrospective analysis of patients admitted for acute appendicitis and undergoing appendectomy between January 2014 and December 2017 was performed in order to assess the possible existence of preoperative analytical predictive factors for complicated acute appendicitis (such as leukocytosis, C-reactive protein and ratio between neutrophils and lymphocytes).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - uncomplicated appendicitis | – | Other: dosing of inflammatory parameters |
| Group 2 - complicated appendicitis | – | Other: dosing of inflammatory parameters |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted for acute appendicitis
Key inclusion criteria (1 listed)
- all patients admitted for acute appendicitis
Key exclusion criteria (1 listed)
- excluded if no existence of dosing of all the inflammatory parameters cited above
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 |
|---|---|---|
| dosing of inflammatory parametersView and register the dosing of inflammatory parameters | Other | Group 1 - uncomplicated appendicitis, Group 2 - complicated appendicitis |
Primary outcome
C-reactive protein dosage
Time frame: 4 years
Leukocytosis dosage
Time frame: 4 years
Ratio between neutrophils and lymphocytes dosage
Time frame: 4 years
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 10 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Centro Hospitalar do Tâmega e Sousa.
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 1 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
C-reactive protein dosage (time frame: 4 years). The study lists 3 primary outcomes in all. 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 10 Nov 2021.