RecruitingNot ApplicableNCT03458195

Ileal Crohn's Disease and Post-operative Outcome: Prospective Cohort Study of the REMIND Group


Sponsor

Saint-Louis Hospital, Paris, France

Enrollment

575 participants

Start Date

Dec 10, 2009

Study Type

INTERVENTIONAL

Conditions

Summary

Crohn's disease (CD), a chronic inflammatory process in intestinal segments leads to tissue damage. More than two thirds of CD patients need intestinal resection. Symptomatic clinical recurrence occurs in 60% by 10 years. The principal factors affecting postoperative recurrence are active smoking, penetrating disease, perianal lesions history, prior intestinal resection, small bowel resection extent, and prophylaxis treatment absence. Ileocolonoscopy within one year of surgery can predict clinical recurrence risk. Different therapies are proposed after surgery, to prevent post-operative recurrence : Thiopurines, 6-mercaptopurine (positive for clinical and endoscopic postoperative recurrence prevention), Anti-tumour necrosis factor therapy (anti-TNF), the most effective therapy. Intestinal microbiota acts as a central factor in the CD pathogenesis, and fecal stream role is clearly shown. Various changes in luminal flora with a possible link to local inflammation was also demonstrated. Bacteria associated with postoperative recurrence could be more pathogenic as adherent invasive E coli (AIEC), which could be a pathogen in CD through several mechanisms including increased mucosal colonization, adherence, replication and induction of TNF secretion. Alternatively, postoperative CD recurrence could be linked to a protective commensal species lack, such as Faecalibacterium prausnitzii. Microscopic inflammation occurs as early as 8 days after anastomosis in the neoterminal ileum mucosa. IL6, IL10 and TGFb levels, measured in neoterminal ileum early after surgery are associated with different rates of postoperative recurrence. It suggests cytokines implication in postoperative recurrence. T cells are major players in the intestinal immune response. The presence at time of surgery and persistence of disease inducing T cell clonal expansions could play an important role in post-operative recurrence. The main objective is to define a classification of ileal Crohn's Disease based on data integration on a large cohort of patients.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is following patients with Crohn's disease of the small intestine (ileum) who need surgery to remove a portion of the bowel, to understand what factors predict whether the disease will come back after surgery and how quickly. **You may be eligible if...** - You are 18 or older - You have been diagnosed with Crohn's disease - You are scheduled for or have recently had surgery to remove the end of the small intestine and part of the large intestine (ileocecal resection) - You are willing and able to follow the study procedures **You may NOT be eligible if...** - You have had previous cancer or abnormal cell growth (dysplasia) in the ileum or colon - You are pregnant - You are unable or unwilling to follow the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERbio-banking collection

blood samples, biopsies, and surgical specimen collected in addition to usual practice


Locations(17)

SART Tilman Hospital

Liège, Belgium

Amiens Hospital

Amiens, France

Haut-levêque Hospital

Bordeaux, France

Clermont-Ferrand Hospital

Clermont-Ferrand, France

Beaujon Hospital

Clichy, France

Henri Mondor Hospital

Créteil, France

Kremlin-Bicêtre Hospital

Le Kremlin-Bicêtre, France

Lille Hospital

Lille, France

Hôpital Nord, CHU Marseille

Marseille, France

Montpellier Hospital

Montpellier, France

Brabois Hospital

Nancy, France

Nantes Hospital

Nantes, France

Archet 2 Hospital

Nice, France

Saint Louis Hospital

Paris, France

Saint Antoine Hospital

Paris, France

South Lyon Hospital

Pierre-Bénite, France

Strasbourg Hospital

Strasbourg, France

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NCT03458195


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