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| Name | Class |
|---|---|
| Wuxi No. 2 People's Hospital | OTHER |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tubing-group | Experimental | mid-gut tubing prior to the MRE examination, administer contrast solution through the mid-gut tube |
|
| Oral-group | No Intervention | administer contrast solution orally, mid-gut tubing after the MRE examination |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mid-gut tubing | Other | mid-gut tubing at different time |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faming Zhang, MD, PhD | The Second Hospital of Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fmt-Dt-N-27/1350 | Nanjing | Jiangsu | 210011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14634782 | Background | Ajaj W, Goehde SC, Schneemann H, Ruehm SG, Debatin JF, Lauenstein TC. Oral contrast agents for small bowel MRI: comparison of different additives to optimize bowel distension. Eur Radiol. 2004 Mar;14(3):458-64. doi: 10.1007/s00330-003-2177-0. Epub 2003 Nov 22. | |
| 25168749 | Background | Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| one year |
| 17899102 | Background | Masselli G, Casciani E, Polettini E, Gualdi G. Comparison of MR enteroclysis with MR enterography and conventional enteroclysis in patients with Crohn's disease. Eur Radiol. 2008 Mar;18(3):438-47. doi: 10.1007/s00330-007-0763-2. Epub 2007 Sep 25. |
| 17483955 | Background | Negaard A, Paulsen V, Sandvik L, Berstad AE, Borthne A, Try K, Lygren I, Storaas T, Klow NE. A prospective randomized comparison between two MRI studies of the small bowel in Crohn's disease, the oral contrast method and MR enteroclysis. Eur Radiol. 2007 Sep;17(9):2294-301. doi: 10.1007/s00330-007-0648-4. Epub 2007 May 5. |
| 29534703 | Background | Long C, Yu Y, Cui B, Jagessar SAR, Zhang J, Ji G, Huang G, Zhang F. A novel quick transendoscopic enteral tubing in mid-gut: technique and training with video. BMC Gastroenterol. 2018 Mar 13;18(1):37. doi: 10.1186/s12876-018-0766-2. |
| 39346010 | Derived | Wang Y, Dai M, Zheng M, Jin Y, Wen Q, Cui B, Zhang Z, Zhu J, Zhang F. Bowel preparation after mid-gut tubing enhanced the efficacy and compliance of magnetic resonance enterography in Crohn's disease: a randomized controlled trial. Ther Adv Gastroenterol. 2024 Sep 26;17:17562848241275337. doi: 10.1177/17562848241275337. eCollection 2024. |
| 30606236 | Derived | Dai M, Zhang T, Li Q, Cui B, Xiang L, Ding X, Rong R, Bai J, Zhu J, Zhang F. The bowel preparation for magnetic resonance enterography in patients with Crohn's disease: study protocol for a randomized controlled trial. Trials. 2019 Jan 3;20(1):1. doi: 10.1186/s13063-018-3101-x. |
| D007410 | Intestinal Diseases |