Colonic DiverticulitisNCT01008488
Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis
A study testing Antibiotic in people with Colonic Diverticulitis, run by Uppsala University at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate if antibiotic therapy is necessary for treatment of uncomplicated colonic diverticulitis. The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colonic Diverticulitis
- What is being tested?
- Antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2002to Dec 2010
- 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
- adults with CT sign of acute colonic uncomplicated diverticulitis
- elevated CRP and LPK
- Temp.38c or more
Who cannot join
- patients with peritonitis, sepsis or CT- sign of complicated diverticulitis with abscesses or free abdominal air
- pregnancy
- immunological incompetence and immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Antibiotic Therapy Mandatory for Treatment of Uncomplicated Acute Colonic Diverticulitis: a Randomized Clinical Trial
The purpose of this study is to evaluate if antibiotic therapy is necessary for treatment of uncomplicated colonic diverticulitis.
The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to complications.
The patients will be randomized to conservative treatment with and without antibiotic therapy.
- Conditions
- Colonic Diverticulitis
- Being tested
- Antibiotic
- Keywords
- colonic diverticulitis, diverticular disease, antibiotic therapy
- Medical subject headings
- Diverticulitis, Colonic, Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
Antibiotic according to local treatment routine against bowel pathogenesis
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic | Active comparator | Not described Receives: Drug: Antibiotic |
| No antibiotic | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
discharge without complications +/- antibiotic therapy
Measured: Within 30 days after discharge
Secondary outcomes (1)
to evaluate length of hospital stay, cost and late complications
Measured: one year after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startNov 2002
- Primary completionMay 2010
- Study completionDec 2010
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 Colonic DiverticulitisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Landstinget i Värmland
- Responsible party
- Principal investigator, achabok, Uppsala University
- Investigators
- Kenneth Smedh, Principal investigator, Center of Clinical Research, Västerås
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008488
- Sponsor's protocol ID
- AVOD-D33
- Status last verified
- Dec 2011
- First submitted
- 4 Nov 2009
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chabok A, Pahlman L, Hjern F, Haapaniemi S, Smedh K; AVOD Study Group. Randomized clinical trial of antibiotics in acute uncomplicated diverticulitis. Br J Surg. 2012 Apr;99(4):532-9. doi: 10.1002/bjs.8688. Epub 2012 Jan 30.
PubMed 22290281
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Antibiotic Therapy Mandatory for Treatment of Uncomplicated Acute Colonic Diverticulitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01008488
- Acronym / sponsor ID
- AVOD-D33
- Conditions
- Colonic Diverticulitis
- Keywords
- colonic diverticulitis, diverticular disease, antibiotic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Landstinget i Värmland
- Study start
- Nov 2002
- Primary completion
- May 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Nov 2009 (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 evaluate if antibiotic therapy is necessary for treatment of uncomplicated colonic diverticulitis.
The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to complications.
The patients will be randomized to conservative treatment with and without antibiotic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic | Active comparator | Drug: Antibiotic |
| No antibiotic | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults with CT sign of acute colonic uncomplicated diverticulitis
- elevated CRP and LPK
- Temp.38c or more
Key exclusion criteria (3 listed)
- patients with peritonitis, sepsis or CT- sign of complicated diverticulitis with abscesses or free abdominal air
- pregnancy
- immunological incompetence and immunosuppressive therapy
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 |
|---|---|---|
| AntibioticAntibiotic according to local treatment routine against bowel pathogenesis | Drug | Antibiotic |
Primary outcome
discharge without complications +/- antibiotic therapy
Time frame: Within 30 days after discharge
1 secondary outcome
to evaluate length of hospital stay, cost and late complications
Time frame: one year after admission
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 23 Dec 2011.
- Derived from this study: PubMed 22290281Chabok A, Pahlman L, Hjern F, Haapaniemi S, Smedh K; AVOD Study Group. Randomized clinical trial of antibiotics in acute uncomplicated diverticulitis. Br J Surg. 2012 Apr;99(4):532-9. doi: 10.1002/bjs.8688. Epub 2012 Jan 30.
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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.
Kenneth Smedh principal investigator
Center of Clinical Research, Västerås
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic in people with Colonic Diverticulitis, run by Uppsala University at 1 site in Sweden.
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 3 inclusion and 3 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 23 Dec 2011. 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 Sweden. 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?
discharge without complications +/- antibiotic therapy (time frame: Within 30 days after discharge). 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 NCT01008488, 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 23 Dec 2011.