DiverticulitisNCT02219698
Symptomatic Treatment of Acute Uncomplicated Diverticulitis
A study testing Ibuprofen and Paracetamol in people with Diverticulitis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diverticulitis
- What is being tested?
- Ibuprofen and Paracetamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteFinland
- Study dates
- Jul 2014to Jul 2015
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Computed tomography-diagnosed acute uncomplicated* diverticulitis
- No abscess, fistula, obstruction and distant intra- or retroperitoneal air. Pericolic air allowed.
Who cannot join
- Already commenced antimicrobial medication
- Immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive medication, chemotherapy, chronic liver disease)
- Suspicion of generalized peritonitis
- Organ dysfunction
- Another infection requiring antimicrobial medication
- Pregnancy
- Age < 18 years or > 90 years
- Missing written consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.
- Conditions
- Diverticulitis
- Being tested
- Ibuprofen, Paracetamol
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
ParacetamolDrug
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic treatment | Experimental | Not described Receives: Drug: Ibuprofen; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of diverticulitis
Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)
Measured: 30 days from allocation
Secondary outcomes (9)
Length of hospital stay (days)
Measured: At the end of the hospital stay, an expected average of 2 days
Rate of re-admissions
Number patients re-admitted to hospital
Measured: 30 days from discharge
Recurrence of diverticulitis
Number of recurrent diverticulitis within follow-up
Measured: 10 years
Mortality
Number of patients deceased
Measured: 30 days from allocation
Need for elective sigmoid resection
Number of patients that have undergone elective sigmoid resection
Measured: 10 years
Need for emergency surgery for diverticulitis on another admission
Number of patients requiring emergency surgery for diverticulitis on another admission
Measured: 10 years
Commencement of antimicrobial drug
Number of patients that have received antimicrobial drugs
Measured: For the duration of hospital stay, an expected average of 2 days
Late complication of diverticulitis
Number of patients who develop late complications of diverticulitis e.g. fistula, stricture
Measured: 10 years
Stoma rate
Number of patients who receive a stoma
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vatsatautien tutkimussäätiö - foundation, Mary and Georg Ehrnroot's foundation, Finnish Surgical society, Martti I. Turunen Foundation, Governmental competitive funds (EVO)
- Responsible party
- Principal investigator, Ville Sallinen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219698
- Sponsor's protocol ID
- HUS-Dnro122-2014
- Status last verified
- Jul 2015
- First submitted
- 11 Aug 2014
- Last updated
- 31 Jul 2015
- Results posted
- No
Publications
Mali JP, Mentula PJ, Leppaniemi AK, Sallinen VJ. Symptomatic Treatment for Uncomplicated Acute Diverticulitis: A Prospective Cohort Study. Dis Colon Rectum. 2016 Jun;59(6):529-34. doi: 10.1097/DCR.0000000000000579.
PubMed 27145310
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Treatment of Acute Uncomplicated Diverticulitis
- ClinicalTrials.gov ID
- NCT02219698
- Acronym / sponsor ID
- HUS-Dnro122-2014
- Conditions
- Diverticulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Vatsatautien tutkimussäätiö - foundation, Mary and Georg Ehrnroot's foundation, Finnish Surgical society, Martti I. Turunen Foundation, Governmental competitive funds (EVO)
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- First posted
- 19 Aug 2014 (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 purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic treatment | Experimental | Drug: Ibuprofen, Drug: Paracetamol |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Computed tomography-diagnosed acute uncomplicated* diverticulitis
Key exclusion criteria (8 listed)
- Already commenced antimicrobial medication
- Immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive medication, chemotherapy, chronic liver disease)
- Suspicion of generalized peritonitis
- Organ dysfunction
- Another infection requiring antimicrobial medication
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 |
|---|---|---|
| Ibuprofen | Drug | Symptomatic treatment |
| Paracetamol | Drug | Symptomatic treatment |
Primary outcome
Complications of diverticulitis
Time frame: 30 days from allocation
Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)
9 secondary outcomes
Length of hospital stay (days)
Time frame: At the end of the hospital stay, an expected average of 2 days
Rate of re-admissions
Time frame: 30 days from discharge
Recurrence of diverticulitis
Time frame: 10 years
Mortality
Time frame: 30 days from allocation
Need for elective sigmoid resection
Time frame: 10 years
Need for emergency surgery for diverticulitis on another admission
Time frame: 10 years
Commencement of antimicrobial drug
Time frame: For the duration of hospital stay, an expected average of 2 days
Late complication of diverticulitis
Time frame: 10 years
Stoma rate
Time frame: 10 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 31 Jul 2015.
- Derived from this study: PubMed 27145310Mali JP, Mentula PJ, Leppaniemi AK, Sallinen VJ. Symptomatic Treatment for Uncomplicated Acute Diverticulitis: A Prospective Cohort Study. Dis Colon Rectum. 2016 Jun;59(6):529-34. doi: 10.1097/DCR.0000000000000579.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen and Paracetamol in people with Diverticulitis, run by Helsinki University Central 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 2 inclusion and 8 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 31 Jul 2015. 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?
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?
Complications of diverticulitis (time frame: 30 days from allocation). 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 NCT02219698, which also lists 1 linked publication.
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 31 Jul 2015.