Crohn DiseaseNCT04739579
Post-operative CRP Trend After Ileocolic Resection in Crohn's Disease Patients.
An observational study of Crohn Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Our aim is to analyze C-Reactive Protein trends during the post-operative course in Crohn's Disease patients having undergone ileocolic resection and primary anastomosis, for the purpose of anastomotic leak early diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- C-Reactive Protein
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2021to 1 Mar 2021
- 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 undergoing ileocolic resection with primary anastomosis
Who may be able to join
- Crohn's disease patients
- Primary ileocolic anastomosis
- C-Reactive Protein data available in medical file
Who cannot join
- Protective stoma
- Associated resection with or without anastomosis during intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-operative CRP Trend May Lead to Early Diagnosis of Anastomotic Leak After Ileocolic Resection in Crohn's Disease Patients.
Our aim is to analyze C-Reactive Protein trends during the post-operative course in Crohn's Disease patients having undergone ileocolic resection and primary anastomosis, for the purpose of anastomotic leak early diagnosis.
- Conditions
- Crohn Disease
- Being tested
- C-Reactive Protein
- Keywords
- Crohn Disease, Anastomotic Leak, C-Reactive Protein
- Medical subject headings
- Crohn Disease, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Reactive ProteinDiagnostic test
C-Reactive Protein trend in post-operative course
| Study group | Role | What they receive |
|---|---|---|
| Anastomotic Leak | Not described Receives: Diagnostic Test: C-Reactive Protein | |
| Non-Anatomotic Leak | Not described Receives: Diagnostic Test: C-Reactive Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak
Presence of a collection in the area of the anastomosis on computed tomography scan or evident anastomotic dehiscence at reoperation for peritonitis.
Measured: up to 30 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start27 Jan 2021
- Primary completion1 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ADELINE GERMAIN, Central Hospital, Nancy, France
- Investigators
- Adeline Germain, MD, PhD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739579
- Sponsor's protocol ID
- 2020PI287
- Status last verified
- Jun 2021
- First submitted
- 28 Jan 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative CRP Trend May Lead to Early Diagnosis of Anastomotic Leak After Ileocolic Resection in Crohn's Disease Patients.
- ClinicalTrials.gov ID
- NCT04739579
- Acronym / sponsor ID
- 2020PI287
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, Anastomotic Leak, C-Reactive Protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 4 Feb 2021 (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 aim is to analyze C-Reactive Protein trends during the post-operative course in Crohn's Disease patients having undergone ileocolic resection and primary anastomosis, for the purpose of anastomotic leak early diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anastomotic Leak | – | Diagnostic Test: C-Reactive Protein |
| Non-Anatomotic Leak | – | Diagnostic Test: C-Reactive Protein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing ileocolic resection with primary anastomosis
Key inclusion criteria (3 listed)
- Crohn's disease patients
- Primary ileocolic anastomosis
- C-Reactive Protein data available in medical file
Key exclusion criteria (2 listed)
- Protective stoma
- Associated resection with or without anastomosis during intervention
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 |
|---|---|---|
| C-Reactive ProteinC-Reactive Protein trend in post-operative course | Diagnostic test | Anastomotic Leak, Non-Anatomotic Leak |
Primary outcome
Anastomotic leak
Time frame: up to 30 days following surgery
Presence of a collection in the area of the anastomosis on computed tomography scan or evident anastomotic dehiscence at reoperation for peritonitis.
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 1 Jul 2021.
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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.
Adeline Germain, MD, PhD principal investigator
Central Hospital, Nancy, France
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 Crohn Disease, run by Central Hospital, Nancy, France 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 1 Jul 2021. 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?
Anastomotic leak (time frame: up to 30 days following surgery). 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 1 Jul 2021.