Bowel Preparation for Magnetic Resonance Enterography

Not Applicable

Completed

• Conditions: Crohn Disease
• Interventions: Other: mid-gut tubing

• Registration Number: NCT03541733
• Lead Sponsor: The Second Hospital of Nanjing Medical University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2018-05-05
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-30
• Study Start: 2018-06-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tubing-group	mid-gut tubing	mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube

Primary Outcome Measures

Name	Time	Method
degree of discomfort	one year	using a visual 5-grade to describe the severity of nervousness, nausea, vomiting, bloating, abdominal pain, and diarrhea (1 = few, 5 = very severe)
grade of bowel distention	one year	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)

Secondary Outcome Measures

Name	Time	Method
accuracy of lesion detection	one year	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)

Trial Locations

Locations (1)

Fmt-Dt-N-27/1350; 🇨🇳 Nanjing, Jiangsu, China