Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT03541733
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2018-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bowel Preparation for Magnetic Resonance Enterography
Sponsor:
The Second Hospital of Nanjing Medical University
Organization:
Study Overview
Official Title:
The Bowel Preparation for Magnetic Resonance Enterography: a Open Label, Multicenter Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: