Prediction and Close Monitoring of Postoperative Recurrence by Intestinal Ultrasound After Ileocecal Resection in Crohn's Disease Patients (INSIGHT)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: Crohn Disease

Treatments: Diagnostic Test: Intestinal ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT05713409

W21_405 # 21.452

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confirmed diagnosis of Crohn's disease
• undergoing ICR (or re-resection)
• ≥16 years of age

Exclusion criteria

• <16 years of age
• Inability to give informed consent
• Ongoing gastroenteritis
• Deviating stoma
• (Sub)total colectomy
• Obesity (BMI >35 kg/m²)
• Insufficient visualization of the anastomosis AND the neo-terminal ileum at baseline IUS

Trial design

120 participants in 1 patient group

Adult patients with an established diagnosis of CD going through ileocecal resection

Treatment:

Diagnostic Test: Intestinal ultrasound