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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-10

Study Completion Date

2025-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Intestinal ultrasound

Intervention Type DIAGNOSTIC_TEST

As part of the routine care, patients will undergo ileocolonoscopy at 6 months, IUS will be performed 3, 6, 12, 18, 24, 30 and 36 months (using B-mode and CDS) and at 3 and 6 months elastography will be performed on the neo-terminal ileum. Biomarkers (CRP and fecal calprotectine) will be measured according to routine care.

Interventions

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Intestinal ultrasound

As part of the routine care, patients will undergo ileocolonoscopy at 6 months, IUS will be performed 3, 6, 12, 18, 24, 30 and 36 months (using B-mode and CDS) and at 3 and 6 months elastography will be performed on the neo-terminal ileum. Biomarkers (CRP and fecal calprotectine) will be measured according to routine care.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No