Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease: a Prospective Randomized Controlled Multicenter Study

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: capsule endoscopy
* Other: standard small bowel preparation
* Other: Simplified small bowel preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both genders aged over 18 years old With an established diagnosis of Crohn's disease, whether active or quiescent With an indication of a small bowel capsule endoscopy Without any small bowel stricture (patency capsule procedure on the 7 days before the capsule endoscopy) Registered with a social security scheme Having provided their oral consent for the study after appropriate information Exclusion Criteria: - Patients aged below 18 years old Diagnosis of ulcerative colitis or IBD unclassified Presence of an ileostomy Presence of a small bowel syndrome Symptoms suggestive of a small bowel stricture Retention of the patency capsule on an abdominal X-ray performed 48 hours after the ingestion Abdominal pain after the ingestion of the patency capsule Planned abdominal surgery in the next month Known intestinal fistula Swallowing disorders Established diagnosis of delayed gastric emptying or suggestive symptoms Intake of non-steroidal anti-inflammatory drugs (NSAIDs) in the month prior to the capsule endoscopy Intake of oral iron supplementation in the week prior to the capsule endoscopy Intake of oral 5-ASA granules in the week prior to the capsule endoscopy Ongoing pregnancy Presence of a pace-maker or implantable defibrillator Known allergy to polyethylene glycol or to lactose Vulnerable people i.e. adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard small bowel preparation<br>2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule | Other: capsule endoscopy<br>* capsule endoscopy<br>Other: standard small bowel preparation<br>* 2 L of polyethylene glycol and free residue diet the day before the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule<br>|
| Experimental: Simplified small bowel preparation<br>Liquid diet the evening before and water on the morning of the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule | Other: capsule endoscopy<br>* capsule endoscopy<br>Other: Simplified small bowel preparation<br>* Liquid diet the evening before and water on the morning of the capsule endoscopy. 2 mL of Babyspasmyl after ingestion of capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KODA score (entire small bowel) | Small bowel preparation quality (entire small bowel) | through the reading of the capsule endoscopy, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KODA score for each small bowel segment | Small bowel preparation quality (by segment : upper/middle/lower third) | 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) | 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) | 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) | Immediately before the capsule endoscopy | 
| Lewis score | Diagnostic yield evaluation | 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 | 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 | through the reading of the capsule endoscopy, an average of 6 months |