Colon Capsule Endoscopy in Children
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The incidence of Inflammatory Bowel Diseases (IBD) is in a continuous progression both in
      adults as in children. The colonoscopy is considered as the gold standard exam for the
      diagnosis and the follow-up of the patients presenting or suspected to have an IBD. The
      follow-up and financial management of this kind of pathology is very much dependent on the
      quality of the endoscopic images. Because colonoscopy is an expensive and invasive technique
      which assumes a general sedation, many efforts have been done to develop new less expensive
      and less invasive techniques in order to offer alternatives to the classic colon endoscopy.
      One of these new techniques is the colon videocapsule (CVC) endoscopy (PillCam® colon 2 -
      Given Imaging, Yoqneam, Israel). This is a new promising semi-invasive endoscopic technique
      which has been successfully validated with adults. We hypothesize that the CVC can be used in
      children with similar results in terms of efficacy, as is the case for adults.

      This prospective simple blind multicenter study, will investigate the diagnostic value of the
      CVC compared to the conventional colonoscopy under general sedation for the detection and the
      control of colon lesions in children presenting IBD.

      If the feasibility and the efficacy of the colon video capsule technique are also proven for
      use with children, then this new technique might become a very interesting alternative for
      the endoscopic examination of the colon because of being less expensive and less invasive.

      Moreover, this technique would be very useful as a means of lesions detection all along the
      digestive tract and not limited to the colon only.
    


Intervention name(s): Colon videocapsule endoscopy (PillCam colon 2)
Intervention type(s): Device
Intervention description(s): This is a simple blind (blind for the lecture of the CVC record) study to evaluate the diagnostic value of the colon capsule endoscopy for the detection and the control of colon lesions, the feasibility, tolerance and safety of the CVC compared to the conventional colonoscopy under general sedation in children presented with Inflammatory Bowel Disease.
Over one week, the patient will undergo two exams (CVC and colonoscopy under general sedation). The exams will be done by two different physicians.
In order to assess the tolerance, after the completion of both exams, the patients will be asked to answer a "comfort score" questionnaire.
In order to assess the safety of the CVC, the patients will have a follow-up for adverse events over a 3 weeks period after completion of the CVC and only if the colon video capsule was not recovered during the conventional colonoscopy.
Other intervention name(s): PillCam colon 2
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Inflammatory Bowel Disease, colon lesions, colon capsule endoscopy