Ischemic ColitisNCT04662268
Assessment of a Composite Prognostic Score to Predict Severe Forms of Ischemic Colitis
An observational study of Ischemic Colitis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Our objective is to determine a prognostic score including CT, clinical and biological criteria predicting the serious (death / surgery) or non-serious (medical treatment) evolution of ischemic colitis and therefore possibly modify the therapeutic management (propose surgical treatment for a severe form based on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Colitis
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2014to 30 Nov 2020
- 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: Single-center retrospective cohort (center: CHU de Montpellier) of patients admitted between january 2014 and december 2019 at the CHU, over 18 years of age and having presented ischemic colitis during their stay, with completion of an injected abdomino-pelvic scanner within 6 hours of onset of symptoms, then proven by surgery or endoscopy
Who may be able to join
- Age > or = at 18 years old;
- Performing an abdomino-pelvic scan injected within 6 hours of the onset of symptoms;
- Ischemic colitis proven by endoscopy or surgical data.
Who cannot join
- CT scan performed without injection and / or after 6 hours following the onset of symptoms;
- Unproven ischemic colitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of a Composite Prognostic Score to Predict Severe Forms of Ischemic Colitis of Montpellier
Our objective is to determine a prognostic score including CT, clinical and biological criteria predicting the serious (death / surgery) or non-serious (medical treatment) evolution of ischemic colitis and therefore possibly modify the therapeutic management (propose surgical treatment for a severe form based on prognostic score).
- Conditions
- Ischemic Colitis
- Keywords
- Ischemic colitis, computed tomography
- Medical subject headings
- Colitis, Ischemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate of ischemic colitis
Severe (surgery and/or death) or non severe form of ischemic colitis (medical treatment) : analysis of radiological, biological and clinical data is performed at the time of acute episode of ischemic colitis when the patient is admitted to the hospital or during the stay of the patient previously present in the hospital for another condition
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Jan 2014
- Primary completion1 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic ColitisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice TAOUREL, MD-PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662268
- Sponsor's protocol ID
- RECHMPL20_0639
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Composite Prognostic Score to Predict Severe Forms of Ischemic Colitis of Montpellier
- ClinicalTrials.gov ID
- NCT04662268
- Acronym / sponsor ID
- RECHMPL20_0639
- Conditions
- Ischemic Colitis
- Keywords
- Ischemic colitis, computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 10 Dec 2020 (actual)
- 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.
Our objective is to determine a prognostic score including CT, clinical and biological criteria predicting the serious (death / surgery) or non-serious (medical treatment) evolution of ischemic colitis and therefore possibly modify the therapeutic management (propose surgical treatment for a severe form based on prognostic score).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single-center retrospective cohort (center: CHU de Montpellier) of patients admitted between january 2014 and december 2019 at the CHU, over 18 years of age and having presented ischemic colitis during their stay, with completion of an injected abdomino-pelvic scanner within 6 hours of onset of symptoms, then proven by surgery or endoscopy
Key inclusion criteria (3 listed)
- Age > or = at 18 years old;
- Performing an abdomino-pelvic scan injected within 6 hours of the onset of symptoms;
- Ischemic colitis proven by endoscopy or surgical data.
Key exclusion criteria (2 listed)
- CT scan performed without injection and / or after 6 hours following the onset of symptoms;
- Unproven ischemic colitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complication rate of ischemic colitis
Time frame: 1 day
Severe (surgery and/or death) or non severe form of ischemic colitis (medical treatment) : analysis of radiological, biological and clinical data is performed at the time of acute episode of ischemic colitis when the patient is admitted to the hospital or during the stay of the patient previously present in the hospital for another condition
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 10 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Patrice TAOUREL, MD-PhD study director
University Hospital, Montpellier
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 Ischemic Colitis, run by University Hospital, Montpellier at 1 site in France.
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 2 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 10 Dec 2020. 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 France. 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?
Complication rate of ischemic colitis (time frame: 1 day). 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 10 Dec 2020.