The European guidelines currently recommend to use 2 L of polyethylene glycol and free residue diet before any capsule endoscopy. However, up to now, no studies have been conducted to specifically evaluate bowel preparation modalities before small bowel capsule endoscopy in patients with Crohn's disease. In patients with Crohn's disease and small bowel ulcers, polyethylene glycol may remove some fibrin from these ulcers and alter bowel preparation. Moreover, it is important to select the most acceptable bowel preparation because patients with Crohn's disease will have to repeat capsule endoscopy several times after initiating treatment, for monitoring under treatment, or for detection of post-operative recurrence. In a preliminary retrospective study, it has been suggested that a simplified bowel preparation with liquid diet the evening before and water on the morning of the capsule endoscopy induced a better bowel preparation than the standard method with polyethylene glycol. Thus, the aim of the study is to demonstrate the superiority of this simplified bowel preparation compared to the standard preparation modality in terms of quality of bowel preparation, patient's acceptability and diagnostic yield.
Crohn's disease is a chronic inflammatory bowel disease characterized by the presence of ulcers that can affect the entire digestive tract, from the mouth to the anus. The existence of small bowel lesions is pejorative and associated with poorer outcomes and a higher risk of intestinal resection. Small bowel capsule endoscopy allows the visualization of the entire small bowel in a non-invasive and outpatient setting, without any anesthesia. It is the exam with the best diagnostic yield for the detection of small bowel ulcers in patients with Crohn's disease. Moreover, it allows the monitoring of patients after initiating treatment to assess mucosal healing and the detection of post-operative recurrence. As for any endoscopic examinations, its acceptability depends on bowel preparation modalities. The European Society of Gastrointestinal Endoscopy (ESGE) currently recommends to use 2 L of polyethylene glycol and free residue diet before any capsule endoscopy. However, patients with Crohn's disease were a minority (\< 1.5 %) in the studies on which these guidelines are based on. Yet, in patients with small bowel Crohn's disease, polyethylene glycol may remove some fibrin from the ulcers and hence, alter bowel preparation. Moreover, it is important to select the most acceptable bowel preparation because patients with Crohn's disease will have to repeat capsule endoscopy several times after initiating treatment, for monitoring under treatment, or for detection of post-operative recurrence. A preliminary retrospective study suggested that a simplified bowel preparation with liquid diet the evening before and water on the morning of the capsule endoscopy induced a better bowel preparation than the standard method with polyethylene glycol. Thus, the aim of CROHN-PREP study is to demonstrate the superiority of this simplified bowel preparation compared to the standard preparation modality in terms of quality of bowel preparation, patient's acceptability and diagnostic yield.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
144
capsule endoscopy
2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule
Liquid diet the evening before and water on the morning of the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule
Angers University Hospital
Angers, France
Vendée departmental hospital
La Roche-sur-Yon, France
Clinique Jules Verne
Nantes, France
Hopital privé Confluent
Nantes, France
Nantes University Hospital
Nantes, France
Rennes University hospital
Rennes, France
KODA score (entire small bowel)
Small bowel preparation quality (entire small bowel)
Time frame: through the reading of the capsule endoscopy, an average of 6 months
KODA score for each small bowel segment
Small bowel preparation quality (by segment : upper/middle/lower third)
Time frame: through the reading of the capsule endoscopy, an average of 6 months
Qualitative assessment by the reader
Proportion of images in which preparation is considered as "good", "moderate" or "low" by the reader (by segment)
Time frame: through the reading of the capsule endoscopy, an average of 6 months
Quantitative assessment of acceptability of preparation
Patient's acceptability of the bowel preparation on a visual analog scale between 0 (nil) to 10 (excellent)
Time frame: Immediately before the capsule endoscopy
Quantitative assessment on a visual analog scale between 0 (nil) to 10 (excellent)
Patient's acceptability of the examination on a visual analog scale between 0 (nil) to 10 (excellent)
Time frame: Immediately before the capsule endoscopy
Lewis score
Diagnostic yield evaluation
Time frame: through the reading of the capsule endoscopy, an average of 6 months
complete examinations
Percentage of complete examinations defined by the visualization of the first duodenal image and the first caecal image
Time frame: through the reading of the capsule endoscopy, an average of 6 months
Small bowel transit time
Recording time between the visualization of the first duodenal image and the first caecal image, if visualized
Time frame: through the reading of the capsule endoscopy, an average of 6 months
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