- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04739579
Post-operative CRP Trend After Ileocolic Resection in Crohn's Disease Patients.
June 30, 2021 updated by: ADELINE GERMAIN, Central Hospital, Nancy, France
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
59
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nancy, France
- CHRU de Nancy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing ileocolic resection with primary anastomosis
Description
Inclusion Criteria:
- Crohn's disease patients
- Primary ileocolic anastomosis
- C-Reactive Protein data available in medical file
Exclusion Criteria:
- Protective stoma
- Associated resection with or without anastomosis during intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Anastomotic Leak
|
C-Reactive Protein trend in post-operative course
|
Non-Anatomotic Leak
|
C-Reactive Protein trend in post-operative course
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 30 days following surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adeline Germain, MD, PhD, Central Hospital, Nancy, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 27, 2021
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
January 28, 2021
First Submitted That Met QC Criteria
February 1, 2021
First Posted (Actual)
February 4, 2021
Study Record Updates
Last Update Posted (Actual)
July 1, 2021
Last Update Submitted That Met QC Criteria
June 30, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020PI287
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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