Abstract
BackgroundThe 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.MethodsThis 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.DiscussionIf 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 registrationClinical Trials.gov, ID: NCT03769922. Registered on February 27, 2019.
Highlights
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)
There has been no prospective trial comparing wide mesocolic resection with conventional surgery in CD. The objective of this multicenter, single-blind, randomized controlled trial is to determine whether there is a reduction in the rate of postoperative recurrence of CD following extensive mesenteric excision (EME), when compared to that of conventional limited mesenteric excision (LME) for ileocolic disease
Our hypothesis is that the inclusion of the mesentery during resection of bowel leads to improvement in the natural history of CD
Summary
Study population Patients with CD limited to the distal ileum and/or right colon receiving their index ileocolic resection are eligible for inclusion. If the outcomes are very poor, more than would be expected, a clear-cut trend towards increased severe morbidity (classed as Clavien-Dindo grade 3 or greater) in relation to either the control or test group, the trial would be stopped and the enrolled participants would have been followed for outcomes and the primary analysis would have focused on the mortality end point. If there was a clear difference between the two groups in terms of benefits for the test cohort, with statistically significant findings emerging on comparison of one group over another that support uncontestable differences between groups, it might be stopped and all enrolled participants will be followed for outcomes and the primary analysis will focus on the efficacy end point. Cessation of trial The trial will stop in three circumstances: (1) once 5 years after first enrollment has been reached; (2) statistically significant findings emerge on comparison of one group over another that support uncontestable differences between groups; and (3) a clear-cut trend is demonstrated toward increasingly severe morbidity (classified as Clavien-Dindo grade 3 or greater) in either treatment arm
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