DiverticulitisPhase 401DIVERNCT01081054
Hospitalization or Ambulatory Treatment of Acute Diverticulitis
A Phase 4 study testing Ambulatory versus hospitalisation in people with Diverticulitis, run by Hospital Universitari de Bellvitge at 5 sites in Spain.
Trial summary
The purpose of 01DIVER is to evaluate efficacy and safety of a home treatment protocol for non complicated diverticulitis compared with management in the hospital. The hypothesis is that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not inferior to the conservative management in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis
- What is being tested?
- Ambulatory versus hospitalisation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 5 sitesSpain
- Study dates
- Sep 2009to Jun 2012
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years
- Diagnosis of mild diverticulitis by abdominal computerized tomography
- Signed informed consent
Who cannot join
- Severe diverticulitis
- Informed consent not signed
- Suspicion of colon cancer
- Pneumoperitoneum
- Intolerance for oral feeding
- Antibiotics for diverticulitis in the last month
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- Immunosuppression
- Pregnancy or lactation
- Severe (decompensated) other illness
- Psychological or social problems
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitari de la Vall d´Hebron
Barcelona, Barcelona, 08035
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Girona, 17007
Hospital Universitari Bellvitge, Colorectal Unit
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Virgen del Camino
Pamplona, Navarre, 31008
Hospital Clinico Universitario De Valencia
Valencia, Valencia, 46010
About this study
Official title: Randomized Trial Comparing Two Treatment Strategies for Acute Diverticulitis. Hospitalization or Ambulatory Antibiotic Treatment
The purpose of 01DIVER is to evaluate efficacy and safety of a home treatment protocol for non complicated diverticulitis compared with management in the hospital. The hypothesis is that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not inferior to the conservative management in hospital in patients with acute not complicated sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively randomized to conservative antibiotic treatment either to ambulatory or to hospital treatment.
- Conditions
- Diverticulitis
- Being tested
- Ambulatory versus hospitalisation
- Keywords
- Diverticulitis, Not complicated diverticulitis
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory versus hospitalisationOther
Patients are treated with the same antibiotic agent, the difference between the two arms is endovenous treatment for hospitalized patients for the first days till oral feeding. The ambulatory group starts directly with orally administered antibiotic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory Treatment | Other | Patients are treated ambulatory with oral antibiotic for 10 days; for the first five days these patients are contacted by telephone daily to progress oral intake. Receives: Other: Ambulatory versus hospitalisation |
| Hospital treatment | Active comparator | Patients are hospitalized and treated with antibiotic, for the first days by endovenous antibiotic and with diet progression orally. Receives: Other: Ambulatory versus hospitalisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Failure of the conservative treatment within 30 days after randomization which consists in one or more of the mentioned signs: persistent or increasing pain, treatment resistant fever, intestinal oclusion, necesity to drain a new intra-abdominal abscess, indication for surgery, mortality.
Measured: 30 days
Secondary outcomes (1)
Recurrence, quality of life, costs
Recurrence of diverticulitis within 30 days; quality of life and patient satisfaction is asessed comparing management with and without admittance to the hospital and costs are calculated for the treatment in both regimens.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastiano Biondo, Hospital Universitari de Bellvitge
- Investigators
- Sebastiano Biondo, MD, PhD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081054
- Sponsor's protocol ID
- 01DIVER
- Other IDs
- 2008-008452-17, 2008
- Acronym
- 01DIVER
- Status last verified
- Jun 2012
- First submitted
- 4 Mar 2010
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Two Treatment Strategies for Acute Diverticulitis. Hospitalization or Ambulatory Antibiotic Treatment
- ClinicalTrials.gov ID
- NCT01081054
- Acronym / sponsor ID
- 01DIVER / 01DIVER
- Conditions
- Diverticulitis
- Keywords
- Diverticulitis, Not complicated diverticulitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Mar 2010 (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 01DIVER is to evaluate efficacy and safety of a home treatment protocol for non complicated diverticulitis compared with management in the hospital. The hypothesis is that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not inferior to the conservative management in hospital in patients with acute not complicated sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively randomized to conservative antibiotic treatment either to ambulatory or to hospital treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory Treatment | Other | Other: Ambulatory versus hospitalisationPatients are treated ambulatory with oral antibiotic for 10 days; for the first five days these patients are contacted by telephone daily to progress oral intake. |
| Hospital treatment | Active comparator | Other: Ambulatory versus hospitalisationPatients are hospitalized and treated with antibiotic, for the first days by endovenous antibiotic and with diet progression orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age older than 18 years
- Diagnosis of mild diverticulitis by abdominal computerized tomography
- Signed informed consent
Key exclusion criteria (10 listed)
- Severe diverticulitis
- Informed consent not signed
- Suspicion of colon cancer
- Pneumoperitoneum
- Intolerance for oral feeding
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 |
|---|---|---|
| Ambulatory versus hospitalisationPatients are treated with the same antibiotic agent, the difference between the two arms is endovenous treatment for hospitalized patients for the first days till oral feeding. The ambulatory group starts directly with orally administered antibiotic treatment. | Other | Ambulatory Treatment, Hospital treatment |
Primary outcome
Treatment failure
Time frame: 30 days
Failure of the conservative treatment within 30 days after randomization which consists in one or more of the mentioned signs: persistent or increasing pain, treatment resistant fever, intestinal oclusion, necesity to drain a new intra-abdominal abscess, indication for surgery, mortality.
1 secondary outcome
Recurrence, quality of life, costs
Time frame: 30 days
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 12 Jun 2012.
Related trials for Diverticulitis
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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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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.
Sebastiano Biondo, MD, PhD principal investigator
Hospital Universitari de Bellvitge
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ambulatory versus hospitalisation in people with Diverticulitis, run by Hospital Universitari de Bellvitge at 5 sites 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 3 inclusion and 10 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 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Treatment failure (time frame: 30 days). 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 12 Jun 2012.