Acute DiverticulitisNCT05162560
Incidence and Outcome of Acute Diverticulitis in Finland
An observational study of Acute Diverticulitis, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The incidence of acute diverticulitis (AD), conservative vs. surgical treatment and outcome of patients are studied using national registries and patient charts from two hospitals between years 2009-19. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Diverticulitis
- What is being tested?
- patients with acute diverticulitis
- How many people
- 15,000 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2009to 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 to 100 years
- All sexes
- Adult, Older adult
Study population: patients with acute diverticulitis is whole Finland and in two study hospitals during years 2009-2019
Who may be able to join
- all patients with acute diverticulitis (K57) in Finland and in two hospitals
Who cannot join
- other reasons for acute or chronic abdominal pain
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Mikkeli Central Hospital
Mikkeli, 50100
Hannu EK Paajanen, MD, +358405263101, paajanen@surffi.fi
About this study
Official title: Incidence of Acute Diverticulitis in Finland: Nationwide Register Study of Epidemiology and Outcome of Treatment Between 2009-19
The incidence of acute diverticulitis (AD), conservative vs. surgical treatment and outcome of patients are studied using national registries and patient charts from two hospitals between years 2009-19.
Read the detailed description
Acute diverticulitis (AD) of colon is increasing in Finland. Incidence, prevalence and mortality of AD of colon are investigated during 10-year period (2009-2019) in whole country. Epidemiological data is compared to data of acute appendicitis. Nationwide data of patients with AD are asked from Finnish Institute for Health and Welfare (THL). To compare registry-based nationwide data, patient charts from electronic database of two hospitals (Mikkeli Central Hospital and Tampere University Hospital) are reviewed from same study period. Patient characteristics, medication, treatment (conservative vs surgery), recurrence of AD and long-term outcome are recorded.
- Conditions
- Acute Diverticulitis
- Being tested
- patients with acute diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with acute diverticulitisOther
registry and hospital charts of patients with acute diverticulitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of annual incidence and prevalence of acute diverticulitis
how many patients with acute diverticulitis are treated in all hospitals in Finland
Measured: January 2009-December 2019
Secondary outcomes (2)
Number of patients with surgical or conservative treatment
Number of patients with conservative or surgical treatment of acute diverticulitis in two hospitals
Measured: January 2009-December 2019
Number of treatment complications and survival of patients with acute diverticulitis
outcome of patients with acute diverticulitis in two hospitals
Measured: January 2009-December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Jan 2009
- Primary completion1 Dec 2021
- 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 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Mikkeli Central Hospital
- Responsible party
- Sponsor
- Investigators
- Hannu EK Paajanen, MD, Principal investigator, Eastern Univerisity of Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162560
- Sponsor's protocol ID
- 5200661
- Status last verified
- Mar 2024
- First submitted
- 25 Oct 2021
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Acute Diverticulitis in Finland: Nationwide Register Study of Epidemiology and Outcome of Treatment Between 2009-19
- ClinicalTrials.gov ID
- NCT05162560
- Acronym / sponsor ID
- 5200661
- Conditions
- Acute Diverticulitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Mikkeli Central Hospital
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Dec 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.
The incidence of acute diverticulitis (AD), conservative vs. surgical treatment and outcome of patients are studied using national registries and patient charts from two hospitals between years 2009-19.
Detailed description
Acute diverticulitis (AD) of colon is increasing in Finland. Incidence, prevalence and mortality of AD of colon are investigated during 10-year period (2009-2019) in whole country. Epidemiological data is compared to data of acute appendicitis. Nationwide data of patients with AD are asked from Finnish Institute for Health and Welfare (THL). To compare registry-based nationwide data, patient charts from electronic database of two hospitals (Mikkeli Central Hospital and Tampere University Hospital) are reviewed from same study period. Patient characteristics, medication, treatment (conservative vs surgery), recurrence of AD and long-term outcome are recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with acute diverticulitis is whole Finland and in two study hospitals during years 2009-2019
Key inclusion criteria (1 listed)
- all patients with acute diverticulitis (K57) in Finland and in two hospitals
Key exclusion criteria (1 listed)
- other reasons for acute or chronic abdominal pain
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 |
|---|---|---|
| patients with acute diverticulitisregistry and hospital charts of patients with acute diverticulitis | Other | – |
Primary outcome
Rate of annual incidence and prevalence of acute diverticulitis
Time frame: January 2009-December 2019
how many patients with acute diverticulitis are treated in all hospitals in Finland
2 secondary outcomes
Number of patients with surgical or conservative treatment
Time frame: January 2009-December 2019
Number of treatment complications and survival of patients with acute diverticulitis
Time frame: January 2009-December 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Improving the Treatment of Acute Uncomplicated Diverticulitis in Routine Care
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APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
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Analysis of the Role of the Microbiota in Diverticular Disease
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Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study
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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.
Hannu EK Paajanen, MD principal investigator
Eastern Univerisity of Finland
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 Diverticulitis, run by Kuopio University Hospital at 1 site in Finland.
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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. 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 Finland. 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?
Contact Hannu EK Paajanen, MD (+358405263101, paajanen@surffi.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of annual incidence and prevalence of acute diverticulitis (time frame: January 2009-December 2019). 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 7 Mar 2024.