INSIGHT
Research type
Research Study
Full title
PredIctioN and cloSe monItorinG of postoperative recurrence by intestinal ultrasound after ileocecal resection in CroHn’s disease patienTs: the INSIGHT study
IRAS ID
324982
Contact name
Maarten Pruijt
Contact email
Sponsor organisation
Amsterdam Academic Medical Center
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Crohn’s disease (CD) is an inflammatory bowel disease causing chronic transmural inflammation followed by intestinal complications including strictures, 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 are very often observed again after the operation. Eventually 15-20% of patients will require new surgery within 5 years. Close monitoring for postoperative recurrence is needed to perform early intervention and prevent clinical recurrence and need for re-surgery. Endoscopy within 1 year from surgery is the gold standard to assess postoperative disease recurrence however it is limited by its invasiveness. Cross sectional imaging, like MRI, CT, or intestinal ultrasound (IUS), are known for accurate detection of postoperative recurrence. In addition, 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.
The primary aim of the study is to investigate if IUS (with or without faecal calprotectin) is suitable to predict and/or to detect early post-operative disease recurrence in patients with Crohn’s disease after ICR.
All the patients, older than 15 years, with an established diagnosis of CD going through an ileocecal resection can be enrolled.
As part of the routine care, patients will undergo ileocolonoscopy at 6 months. An IUS will be performed 3, 6, 12, 18, 24, 30 and 36 months after surgery. Bloods and stool sample will be collected at each ultrasound appointment to correlate those result with the ultrasound.REC name
London - Brent Research Ethics Committee
REC reference
23/PR/0602
Date of REC Opinion
26 Sep 2023
REC opinion
Further Information Favourable Opinion