The bowel preparation for magnetic resonance enterography in patients with Crohn's disease: study protocol for a randomized controlled trial

Min Dai, Ting Zhang, Qianqian Li, Bota Cui, Liyuan Xiang, Xiao Ding, Rong Rong, Jianling Bai, Jianguo Zhu, Faming Zhang, Min Dai, Ting Zhang, Qianqian Li, Bota Cui, Liyuan Xiang, Xiao Ding, Rong Rong, Jianling Bai, Jianguo Zhu, Faming Zhang

Abstract

Background: Adequate bowel preparation is required for magnetic resonance enterography (MRE), which can be achieved by administering contrast solution after mid-gut tubing or taking contrast solution orally. We present the design of randomized controlled trial (RCT) to compare the efficacy and compliance of bowel preparation between mid-gut tubing and oral administering for MRE in patients with Crohn's disease (CD).

Methods/design: This is an open-label, multicenter RCT. Ninety-six patients with CD in need of MRE examination and mid-gut tubing (prepared for fecal microbiota transplantation and/or enteral nutrition), aged ≥ 14 years, will be included. Patients will be randomized 1:1 into either bowel preparation by oral administering (oral group) or bowel preparation through mid-gut transendoscopic enteral tubing (TET) (tubing group). The primary outcome measures are: (1) degree of discomfort before/during/after bowel preparation for MRE using a visual 5-grade scale (1 = few, 5 = very severe); and (2) 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). The secondary outcome measure is the accuracy of lesion detection through MRE confirmed by colonoscopy which is evaluated by a 5-point scale.

Discussion: The outcome of this study is expected to provide a novel effective clinical protocol of bowel preparation for MRE in patients with CD. We hope to highlight the concept of physician-patient satisfaction based on different methods of bowel preparation for MRE.

Trial registration: ClinicalTrials.gov, NCT03541733 . Registered on 30 May 2018.

Keywords: Bowel preparation; Colonoscopy; Crohn’s disease; Magnetic resonance enterography; Transendoscopic enteral tubing.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Institutional Review Board of the Second Affiliated Hospital of Nanjing Medical University. Written informed consent will be given to all the included patients.

Consent for publication

The patients in Fig. 3 have signed the consent for their images for publication.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the trial
Fig. 2
Fig. 2
SPIRIT figure
Fig. 3
Fig. 3
Methods of bowel preparation. Bowel preparation for MRE through oral administering (a) and mid-gut tubing (b)
Fig. 4
Fig. 4
MR images. A 30-year-old woman with CD for eight years has a big polyp located at the duodenum inducing luminal stricture. Coronal T2-weighted SSFSE MRE (a, c) and coronal T1-weighted enhanced MR (b, d) are shown above. a and b are prepared through oral administering: retention of large volume contrast solution in the stomach and collapsed bowel segments representing terrible bowel distention. c and d are prepared through mid-gut tubing: good distention of small bowel

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