Acute Uncomplicated DiverticulitisNCT05784064
Multicenter Survey About Acute Uncomplicated Diverticulitis Management
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
Acute uncomplicated diverticulitis is a quite prevalent situation and consultation in the emergency department. Its management has progresively changed towards a more conservative one and it is currently recommended in several guidelines the option of avoiding antibiotics in certain highly selected cases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Uncomplicated Diverticulitis
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 13 Dec 2022to 30 Apr 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Every surgeon with emergency surgery activity or colorectal surgeons that work at any Spanish hospital.
Who may be able to join
- Colorectal surgeons.
- Surgeons with emergency surgery activity.
Who cannot join
- Any other medical speciality.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de La Princesa
Madrid, 28060
Alba Correa Bonito, +34675589826, alba.bonito90@gmail.com
About this study
Acute uncomplicated diverticulitis is a quite prevalent situation and consultation in the emergency department.
Its management has progresively changed towards a more conservative one and it is currently recommended in several guidelines the option of avoiding antibiotics in certain highly selected cases.
Read more
Nevertheless, the implantation of such recommendations in current clinical pratice is unknown and, hypothesizing it was still low, the reasons for such reluctancy are also unknown.
Both aspects can be considered quite interesting in order to design a specific plan in order to overcome such difficulties.
In order to do so, an online survery was designed and colorectal surgeons along Spain, based in the census of the Young Group from the Spanish Association of Colorectal Surgery were invited to participate. Invitations were distributed along usual communication channels of this group, such as email or chat mobile phone applications. All the responses to the survey will be analyzed in order to find out how many hospitals are using current managemente without antibiotics, its characteristics and, opposite, what are the main reasons for those hospitals that are not using it yet.
- Conditions
- Acute Uncomplicated Diverticulitis
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
This is a nationalwide survey developed in order to know the management of patients diagnosed of acute uncomplicated diverticulitis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute uncomplicated diverticulitis management without antibiotics
Rate of hospitals that includes management without antibiotics
Measured: 3rd january 2023-30th may 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start13 Dec 2022
- Primary completion10 Apr 2023 (estimated)
- Study completion30 Apr 2023 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784064
- Sponsor's protocol ID
- 4489
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Survey About Acute Uncomplicated Diverticulitis Management
- ClinicalTrials.gov ID
- NCT05784064
- Acronym / sponsor ID
- 4489
- Conditions
- Acute Uncomplicated Diverticulitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 10 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 24 Mar 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.
Acute uncomplicated diverticulitis is a quite prevalent situation and consultation in the emergency department.
Its management has progresively changed towards a more conservative one and it is currently recommended in several guidelines the option of avoiding antibiotics in certain highly selected cases.
Nevertheless, the implantation of such recommendations in current clinical pratice is unknown and, hypothesizing it was still low, the reasons for such reluctancy are also unknown.
Both aspects can be considered quite interesting in order to design a specific plan in order to overcome such difficulties.
In order to do so, an online survery was designed and colorectal surgeons along Spain, based in the census of the Young Group from the Spanish Association of Colorectal Surgery were invited to participate. Invitations were distributed along usual communication channels of this group, such as email or chat mobile phone applications. All the responses to the survey will be analyzed in order to find out how many hospitals are using current managemente without antibiotics, its characteristics and, opposite, what are the main reasons for those hospitals that are not using it yet.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Every surgeon with emergency surgery activity or colorectal surgeons that work at any Spanish hospital.
Key inclusion criteria (2 listed)
- Colorectal surgeons.
- Surgeons with emergency surgery activity.
Key exclusion criteria (1 listed)
- Any other medical speciality.
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 |
|---|---|---|
| SurveyThis is a nationalwide survey developed in order to know the management of patients diagnosed of acute uncomplicated diverticulitis. | Behavioural | – |
Primary outcome
Acute uncomplicated diverticulitis management without antibiotics
Time frame: 3rd january 2023-30th may 2023
Rate of hospitals that includes management without antibiotics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
Related trials for Acute Uncomplicated Diverticulitis
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Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care
Diverticulitis
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.
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 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: status not confirmed, as of the sponsor's last update on 24 Mar 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute uncomplicated diverticulitis management without antibiotics (time frame: 3rd january 2023-30th may 2023). 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 24 Mar 2023.