Acute Uncomplicated DiverticulitisAUDRIPNCT05833698
Acute Uncomplicated Diverticulitis and Conservative Treatment: Accuracy of Inflammatory Indexes for Failure Prediction: Observational Prospective Cohort Study. (AUDRIP Trial)
An observational study of Acute Uncomplicated Diverticulitis, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial summary
This is an observational multicenter study that will analyse the accuracy of inflammatory indexes as neutrophil-lymphocyte ratio and platelet-lymphocyte ratio, to predict the failure of conservative treatment of patients diagnosed of acute uncomplicated diverticulitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Uncomplicated Diverticulitis
- What is being tested?
- Elevation of NLR
- How many people
- 2,160 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2023to 31 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients over 18 years, diagnosed of acute uncomplicated diverticulitis
Who may be able to join
- Patients older than 18, diagnosed of acute uncomplicated diverticulitis.
- Diagnosis made by CT or ultrasound
Who cannot join
- Patients younger than 18.
- Patients diagnosed of acute complicated diverticulitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Uncomplicated Diverticulitis and Conservative Treatment: Accuracy of Inflammatory Indexes for Failure Prediction: Observational Prospective Cohort Study.
This is an observational multicenter study that will analyse the accuracy of inflammatory indexes as neutrophil-lymphocyte ratio and platelet-lymphocyte ratio, to predict the failure of conservative treatment of patients diagnosed of acute uncomplicated diverticulitis.
- Conditions
- Acute Uncomplicated Diverticulitis
- Being tested
- Elevation of NLR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevation of NLRDiagnostic test
Also called Elevation of PLR
Blood test
| Study group | Role | What they receive |
|---|---|---|
| Patients with failure of conservative treatment | Not described Receives: Diagnostic Test: Elevation of NLR | |
| Patients without failure of conservative treatment | Not described Receives: Diagnostic Test: Elevation of NLR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of conservative treatment with antibiotics
Measured: 15th june 2023-31st december 2024
Failure of conservative treatment without antibiotics
Measured: 15th june 2023-31st december 2024
Secondary outcomes (2)
Evaluate the accuracy of PLR and NLR as predictors of failure
Measured: 15th june 2023-31st december 2024
Analysis of trends in managemente of acute uncomplicated diverticulitis
Measured: 15th june 2023-31st december 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start15 Jun 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Uncomplicated DiverticulitisStudies 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
- 2,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alba Correa Bonito, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833698
- Sponsor's protocol ID
- 5072
- Acronym
- AUDRIP
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2023
- Last updated
- 27 Apr 2023
- Results posted
- 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 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Uncomplicated Diverticulitis and Conservative Treatment: Accuracy of Inflammatory Indexes for Failure Prediction: Observational Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05833698
- Acronym / sponsor ID
- AUDRIP / 5072
- Conditions
- Acute Uncomplicated Diverticulitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,160 participants (estimated)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Apr 2023 (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.
This is an observational multicenter study that will analyse the accuracy of inflammatory indexes as neutrophil-lymphocyte ratio and platelet-lymphocyte ratio, to predict the failure of conservative treatment of patients diagnosed of acute uncomplicated diverticulitis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with failure of conservative treatment | – | Diagnostic Test: Elevation of NLR |
| Patients without failure of conservative treatment | – | Diagnostic Test: Elevation of NLR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over 18 years, diagnosed of acute uncomplicated diverticulitis
Key inclusion criteria (2 listed)
- Patients older than 18, diagnosed of acute uncomplicated diverticulitis.
- Diagnosis made by CT or ultrasound
Key exclusion criteria (2 listed)
- Patients younger than 18.
- Patients diagnosed of acute complicated diverticulitis
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 |
|---|---|---|
| Elevation of NLRAlso: Elevation of PLRBlood test | Diagnostic test | Patients with failure of conservative treatment, Patients without failure of conservative treatment |
Primary outcome
Failure of conservative treatment with antibiotics
Time frame: 15th june 2023-31st december 2024
Failure of conservative treatment without antibiotics
Time frame: 15th june 2023-31st december 2024
2 secondary outcomes
Evaluate the accuracy of PLR and NLR as predictors of failure
Time frame: 15th june 2023-31st december 2024
Analysis of trends in managemente of acute uncomplicated diverticulitis
Time frame: 15th june 2023-31st december 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Uncomplicated Diverticulitis
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Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care
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RecruitingPhase 2
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
Acute Uncomplicated Diverticulitis
Enrolling by invitation
Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without Antibiotics
Diverticulitis, Colonic
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.
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 Acute Uncomplicated Diverticulitis, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. 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 Spain. 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?
Results are not available in the source record.
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?
Failure of conservative treatment with antibiotics (time frame: 15th june 2023-31st december 2024). The study lists 2 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 27 Apr 2023.