Urinary ComplicationsNCT00817141
Urinary Catheter and Fast-track Surgery
An observational study of Urinary Complications, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Urinary catheter was placed during several days after colonic surgery. Nevertheless, it is probably unnecessary after Fast-Track colonic surgery. No prospective data permit to confirm it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Complications
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2008to Oct 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for Fast Track colonic surgery
Who may be able to join
- Patients scheduled for Fast Track colonic surgery
Who cannot join
- Urinary pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Urinary Catheter Necessary After Fast-Track Colonic Surgery?
Urinary catheter was placed during several days after colonic surgery. Nevertheless, it is probably unnecessary after Fast-Track colonic surgery. No prospective data permit to confirm it.
- Conditions
- Urinary Complications
- Being tested
- Observational study, no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, no interventionOther
Observation of the complications seen without urinary catheter (which is the habitual protocol in our institution)
| Study group | Role | What they receive |
|---|---|---|
| Without urinary catheter | Not described Receives: Other: Observational study, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urinary retention necessitating catheterisation
Measured: 72 hours
Secondary outcomes (1)
Other urinary complications and modification of the Fast Track protocol
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startMar 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary ComplicationsStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Forget Patrice, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817141
- Sponsor's protocol ID
- 2008/12MARS/82
- Status last verified
- Mar 2017
- First submitted
- 5 Jan 2009
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Urinary Catheter Necessary After Fast-Track Colonic Surgery?
- ClinicalTrials.gov ID
- NCT00817141
- Acronym / sponsor ID
- 2008/12MARS/82
- Conditions
- Urinary Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 6 Jan 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.
Urinary catheter was placed during several days after colonic surgery. Nevertheless, it is probably unnecessary after Fast-Track colonic surgery. No prospective data permit to confirm it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Without urinary catheter | – | Other: Observational study, no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for Fast Track colonic surgery
Key inclusion criteria (1 listed)
- Patients scheduled for Fast Track colonic surgery
Key exclusion criteria (1 listed)
- Urinary pathology
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 |
|---|---|---|
| Observational study, no interventionObservation of the complications seen without urinary catheter (which is the habitual protocol in our institution) | Other | Without urinary catheter |
Primary outcome
Incidence of urinary retention necessitating catheterisation
Time frame: 72 hours
1 secondary outcome
Other urinary complications and modification of the Fast Track protocol
Time frame: 4 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 27 Mar 2017.
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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?
An observational study of Urinary Complications, run by Université Catholique de Louvain at 1 site in Belgium.
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: finished, as of the sponsor's last update on 27 Mar 2017. 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 Belgium. 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?
Incidence of urinary retention necessitating catheterisation (time frame: 72 hours). 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 27 Mar 2017.