Uncomplicated Acute CholecystitisPhase 2NCT00323648
Does it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis
A Phase 2 study testing Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis in people with Uncomplicated Acute Cholecystitis, run by University Hospital, Ghent at 2 sites in 2 countries.
Trial summary
Each patient is preoperatively treated once profylactic with intraveneous antibiotics. Postoperatively, one group will be treated with intraveneous antibiotics during 5 days. The other group will receive no antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncomplicated Acute Cholecystitis
- What is being tested?
- Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2006to Aug 2013
- Phase
- Phase 2
- 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
- Uncomplicated acute cholecystitis < 5 days(confirmed by echography and blood sample)
- > 18 years old
Who cannot join
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Each patient is preoperatively treated once profylactic with intraveneous antibiotics. Postoperatively, one group will be treated with intraveneous antibiotics during 5 days. The other group will receive no antibiotics.
- Conditions
- Uncomplicated Acute Cholecystitis
- Being tested
- Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitisDrug
Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis.
| Study group | Role | What they receive |
|---|---|---|
| postoperatively antibiotics | Experimental | Not described Receives: Drug: Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications (abces, infection of the wound)
Measured: day 2, day of discharge and dag 21
Secondary outcomes (1)
Duration of hospitalisation
Measured: Day O to day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2010
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Acute CholecystitisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederik Berrevoet, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323648
- Sponsor's protocol ID
- 2006/111
- Status last verified
- Dec 2014
- First submitted
- 7 May 2006
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT00323648
- Acronym / sponsor ID
- 2006/111
- Conditions
- Uncomplicated Acute Cholecystitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 May 2006 (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.
Each patient is preoperatively treated once profylactic with intraveneous antibiotics. Postoperatively, one group will be treated with intraveneous antibiotics during 5 days. The other group will receive no antibiotics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| postoperatively antibiotics | Experimental | Drug: Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Uncomplicated acute cholecystitis < 5 days(confirmed by echography and blood sample)
- > 18 years old
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitisWhether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis. | Drug | postoperatively antibiotics |
Primary outcome
Postoperative complications (abces, infection of the wound)
Time frame: day 2, day of discharge and dag 21
1 secondary outcome
Duration of hospitalisation
Time frame: Day O to day of discharge
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 5 Dec 2014.
- Website of the University Hospital GhentLink provided by the sponsor.
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.
Frederik Berrevoet, MD principal investigator
University Hospital, Ghent
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis in people with Uncomplicated Acute Cholecystitis, run by University Hospital, Ghent at 2 sites in 2 countries.
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: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Qatar. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Postoperative complications (abces, infection of the wound) (time frame: day 2, day of discharge and dag 21). 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 5 Dec 2014.