Bowel Preparation for Magnetic Resonance Enterography

Study Overview
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Brief Summary
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Adequate bowel preparation is required for magnetic resonance enterography (MRE) which can be achieved by two methods including administering contrast solution after mid-gut tubing and taking contrast solution orally. We present the design of randomized controlled trial to compare the efficacy and compliance of bowel preparation through mid-gut tubing with taking contrast orally for MRE in patients with Crohn's disease (CD).

Detailed Description
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This is a open label, multicenter, randomized controlled trial. 96 patients are planed to be 1:1 randomized into one of two groups: (1) Tube group, mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube; (2) Oral group, administer contrast solution orally, mid-gut tubing after the MRE examination. The primary outcome measures are: (1) grade of bowel distention evaluated by a 5-grade scale (1 = 0-20% segmental distention, 2 = 20-40% distention, 3 = 40-60% distention, 4 = 60-80% distention, 5 = 80-100% distention); (2) degree of discomfort before/during/after bowel preparation for MRE using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe). The secondary outcome measure is the accuracy of lesion detection through MRE confirmed by endoscopy (within 1 month before MRE and during this hospitalization) will be evaluated by a 5-point scale (lesions locating at the terminal ileum, ileocecal junction, hepatic flexure of colon, splenic flexure of colon, and rectosigmoid colon, consistency of lesion detection from each bowel segment scoring 1 point, otherwise not scoring).

Official Title
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The Bowel Preparation for Magnetic Resonance Enterography: a Open Label, Multicenter Randomized Controlled Trial

Conditions
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Crohn Disease

Intervention / Treatment
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* Other: mid-gut tubing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with CD need MRE examination and mid-gut tubing (prepared for fecal microbiota transplantation and/or enteral nutrition); Age ≥ 14 years old. Exclusion Criteria: Unable to understand or provide informed consent; Had difficulty in swallowing, or dysphagia; Allergic to laxative and/or contrast; Claustrophobia or implanted metal objects or cardiac pacemaker precluding performance of MRI; Known or suspected intestinal obstruction or severe stricture.

Ages Eligible for Study
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Minimum Age: 14 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tubing-group<br>mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube | Other: mid-gut tubing<br>* mid-gut tubing at different time<br>|
| No Intervention: Oral-group<br>administer contrast solution orally, mid-gut tubing after the MRE examination | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grade of bowel distention | grade of bowel distention evaluated by a 5-grade scale (1 = 0-20% segmental distention, 2 = 20-40% distention, 3 = 40-60% distention, 4 = 60-80% distention, 5 = 80-100% distention) | one year | 
| degree of discomfort | using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe) | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of lesion detection | accuracy of lesion detection through MRE confirmed by endoscopy (within 1 month before MRE and during this hospitalization) will be evaluated by a 5-point scale (lesions locating at the terminal ileum, ileocecal junction, hepatic flexure of colon, splenic flexure of colon, and rectosigmoid colon, consistency of lesion detection from each bowel segment scoring 1 point, otherwise not scoring) | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnetic resonance enterography, bowel preparation