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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
SINGLE
Enrollment
52
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.
Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux
Bordeaux, France
Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, France
Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille
Lille, France
Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP
Paris, France
Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP
Paris, France
Service de Pédiatrie, Hôpital Sud, CHU de Rennes
Rennes, France
Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse
Toulouse, France
The diagnostic value of the wireless colon capsule endoscopy
The diagnostic value of the colon video capsule will be estimated based upon the calculated sensitivity of the colon video capsule for the detection and the control of colon lesions in children presented with IBD compared to the colonoscopy sensitivity.
Time frame: 1 week after the completion of the colon video capsule exam .
Diagnostic and predictive value of the colon video capsule
The diagnostic value expressed by the specificity, positive and negative predictive values of the colon video capsule compared to the results of the colonoscopy under general sedation.
Time frame: 1 week after the completion of the colon video capsule exam
Diagnostic performance of the colon video capsule
Percentage of the colon lesions successfully detected by the colon video capsule compared to the results recorded during the colonoscopy.
Time frame: 1 week after the completion of both endoscopic exams
Evaluation of the feasibility and the acceptability by the patient of the colon video capsule compared to the colonoscopy under general sedation
Based upon the comfort score calculated after a comfort questionnaire that the patient has been completed after the colon video capsule exam and colonoscopy have been performed
Time frame: 1 week after the completion of the colon video capsule exam
Evaluation of the efficacy of the bowel preparation before the endoscopic examination of the colon
The evaluation will be done using the Boston score.
Time frame: 1 week after the colon video capsule has been performed
Descriptive analysis of the visualization and the progression of the colon video capsule over the different segments of the bowel
The analysis will be based upon the description of the different lesions and the time of capsule progression in each bowel segment during the video capsule exam. The different segments will be defined taking into account the anatomic landmarks.
Time frame: 1 week after the colon video capsule has been performed
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