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

  • France
      • 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
Diagnostic test: C-Reactive Protein
C-Reactive Protein trend in post-operative course
Non-Anatomotic Leak
Diagnostic test: C-Reactive Protein
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

Central Hospital, Nancy, France

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

Keywords

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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