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

Autor: Yi Li, Helen Mohan, Nan Lan, Xiaojian Wu, Wei Zhou, Jianfeng Gong, Bo Shen, Luca Stocchi, J. Calvin Coffey, Weiming Zhu
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Trials, Vol 21, Iss 1, Pp 1-7 (2020)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-020-4105-x
Popis: 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
Databáze: Directory of Open Access Journals
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