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NCT05713409
Prediction and Close Monitoring of Postoperative Recurrence by Intestinal Ultrasound After Ileocecal Resection in Crohn's Disease Patients
Conditions: Crohn Disease
Sex: All
Ages: 16 Years – N/A
Enrollment: 120
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Location: Germany
Summary
Crohn's disease (CD) is an inflammatory bowel disease causing chronic transmural inflammation followed by intestinal complications including strictures and penetrating lesions such as fistulas and abscesses.
30-50% of the CD patients will require surgery during the course of their disease.
Unfortunately, resection is not curative and endoscopically recurrent lesions (i.e.
endoscopic recurrence) are observed in 65-90% of patients within 12 months, and in 80-100% within 3 years after the operation.
Eventually 15-20% of patients will require new surgery within 5 years.
Close monitoring for postoperative recurrence is therefore needed to perform early intervention and prevent clinical recurrence and need for re-surgery.
Endoscopy is the gold standard to assess postoperative disease recurrence however it's limited by its invasiveness.
Cross sectional imaging is known for accurate detection of postoperative recurrence.
Intestinal ultrasound (IUS) of the colon and (neo)terminal ileum correlates well with CT, MRE and colonoscopy findings in the postoperative setting.
IUS is non-invasive, cheap, readily available and may show early, signs of disease recurrence.
Therefore it could be a useful tool to predict endoscopic recurrence at 6 months.
Eligibility Criteria
Inclusion Criteria:confirmed diagnosis of Crohn's diseaseundergoing ICR (or re-resection)≥16 years of ageExclusion Criteria:<16 years of ageInability to give informed consentOngoing gastroenteritisDeviating stoma(Sub)total colectomyObesity (BMI >35 kg/m²)Insufficient visualization of the anastomosis AND the neo-terminal ileum at baseline IUS
Source: ClinicalTrials.gov (NCT05713409). StuddyBuddy aggregates publicly available trial information.