Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease Clinical Trial
Official title:
Colonoscopy With Low Volume bowEl prepAration in iNflammatory Bowel Diseases
National multicentric observatory of low bowel preparations in patients with IBD
Prospective french multicentre observational study, during one month: from March 6th to April
6th 2017, under the auspice of the IBD group of the Société Française d'Endoscopie Digestive-
SFED. All French gastroenterologists in charge of IBD patients in public or private endoscopy
centers were reached out through various professional and scientific associations to
participate in the study via e-mail, web sites, and national congresses. Investigators were
asked to prescribe the bowel preparation independently from the study, as per their usual
habits. The achievement of low residue diet, the split and the timing of the preparation were
left free to the investigator according to local protocols.
Data recording The physicians participating in the study completed data on an online
questionnaire via an internet-based tool (CleanWeb software, hosted by Besançon university
hospital research center) or through a questionnaire sheet. The questionnaire included a
medical record and a self-reported patient questionnaire. The medical record included
physicians and centers characteristics, patient's demographics, disease characteristics,
modality of bowel preparation (diet, split dose, type of bowel preparation, delay before
colonoscopy), and colonoscopy findings and outcomes. Patients self-administered
questionnaires assessed preparation tolerability by symptoms and satisfaction recording.
Clinical endpoints The efficacy of the preparation was evaluated by the Boston's score
(efficacy was defined as a Boston's score was ≥ 7 without any segment <2)23, the rate of
caecal or anastomosis intubation and the necessity or not to repeat the colonoscopy.
The tolerance was evaluated by the quantity of preparation actually absorbed by the patient,
(quantity of active preparation and quantity of clear liquid), patients and investigators
visual analogue scale evaluation of tolerance (VAS), a self-administered validated
bowel-preparation tolerability questionnaire 24 and by the patients' wish to take the same
preparation for the next colonoscopy.
Safety data: adverse events were collected per preparation and per endoscopic procedure, at
24 hours and 30 days later. A special focus was made on aphtoid lesions as they were
previously reported as adverse preparation-induced mucosal lesions possibly associated with
some solutions.
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