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Published in: Trials 1/2020

Open Access 01-12-2020 | Crohn's Disease | Study protocol

Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial

Authors: Yi Li, Helen Mohan, Nan Lan, Xiaojian Wu, Wei Zhou, Jianfeng Gong, Bo Shen, Luca Stocchi, J. Calvin Coffey, Weiming Zhu

Published in: Trials | Issue 1/2020

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Abstract

Background

The structures of the mesentery including adipose tissue, nerves, and lymphatics play an important role in the pathogenesis and disease progression of Crohn’s disease (CD). Conventional surgical resection for CD usually does not involve resecting the mesentery en bloc with the specimen. This contrasts with complete mesocolic excision (CME) in colorectal cancer, which involves radical resection of the mesentery. Preliminary evidence from smaller studies suggests that applying the principle of mesocolic excision to CD surgery may reduce the risk of postoperative recurrence. This randomized controlled trial is designed to test whether applying the principles of mesocolic excision to CD results in reduced postoperative recurrence. It also aims to evaluate intra- and postoperative morbidity between the two approaches.

Methods

This international, multicenter, randomized controlled trial will randomize patients (n = 116) scheduled to undergo primary ileocolic resection to either receive extensive mesenteric excision (EME) or conventional ileocolic resection with limited mesenteric excision (LME). Five sites will recruit patients in three countries. In the EME group, the mesentery is resected following CME, while avoiding the root region, i.e., 1 cm from the root of the ileocolic artery and vein. In the LME group, the mesentery is retained, i.e., “close shave” or < 3 cm from the border of bowel. The primary end point will be surgical recurrence after surgery. The secondary end points will be the postoperative endoscopic and clinical recurrence, and intra- and postoperative morbidity. Demographics, risk factors, laboratory investigations, endoscopy, postoperative prophylaxis and imaging examination will be assessed. Analysis of the primary outcome will be on an intention-to-treat basis.

Discussion

If mesocolic excision in CD reduces postoperative disease recurrence and does not increase morbidity, this trial has the potential to change practice and reduce recurrence of CD after surgical resection.

Trial registration

Clinical Trials.gov, ID: NCT03769922. Registered on February 27, 2019.
Appendix
Available only for authorised users
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Metadata
Title
Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial
Authors
Yi Li
Helen Mohan
Nan Lan
Xiaojian Wu
Wei Zhou
Jianfeng Gong
Bo Shen
Luca Stocchi
J. Calvin Coffey
Weiming Zhu
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Crohn's Disease
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4105-x

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