Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial
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 sp...
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doaj-f2e98186102b411fb39dfea58ba4f0d32020-11-25T02:37:32ZengBMCTrials1745-62152020-02-012111710.1186/s13063-020-4105-xMesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trialYi Li0Helen Mohan1Nan Lan2Xiaojian Wu3Wei Zhou4Jianfeng Gong5Bo Shen6Luca Stocchi7J. Calvin Coffey8Weiming Zhu9Center for Inflammatory Bowel Diseases, Department of General Surgery, Jinling Hospital, Medical School of Nanjing UniversityDepartment of Surgery, Surgical Professorial Unit, University Hospital LimerickDepartment of Colorectal Surgery, Digestive Disease and Surgery Institute Cleveland ClinicDepartment of Colorectal Surgery, the Sixth Affiliated Hospital of Sun Yat-sen UniversityDepartment of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang UniversityCenter for Inflammatory Bowel Diseases, Department of General Surgery, Jinling Hospital, Medical School of Nanjing UniversitySection of Inflammatory Bowel Diseases and Center for Interventional IBD, Columbia University Irving Medical Center-NewYork PresbyterianDepartment of Colorectal Surgery, Digestive Disease and Surgery Institute Cleveland ClinicDepartment of Surgery, Surgical Professorial Unit, University Hospital LimerickCenter for Inflammatory Bowel Diseases, Department of General Surgery, Jinling Hospital, Medical School of Nanjing UniversityAbstract 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.http://link.springer.com/article/10.1186/s13063-020-4105-xCrohn’s diseaseIleocolic resectionMesenteryPostoperative recurrence |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Yi Li Helen Mohan Nan Lan Xiaojian Wu Wei Zhou Jianfeng Gong Bo Shen Luca Stocchi J. Calvin Coffey Weiming Zhu |
spellingShingle |
Yi Li Helen Mohan Nan Lan Xiaojian Wu Wei Zhou Jianfeng Gong Bo Shen Luca Stocchi J. Calvin Coffey Weiming Zhu Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial Trials Crohn’s disease Ileocolic resection Mesentery Postoperative recurrence |
author_facet |
Yi Li Helen Mohan Nan Lan Xiaojian Wu Wei Zhou Jianfeng Gong Bo Shen Luca Stocchi J. Calvin Coffey Weiming Zhu |
author_sort |
Yi Li |
title |
Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial |
title_short |
Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial |
title_full |
Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial |
title_fullStr |
Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial |
title_full_unstemmed |
Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial |
title_sort |
mesenteric excision surgery or conservative limited resection in crohn’s disease: study protocol for an international, multicenter, randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2020-02-01 |
description |
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. |
topic |
Crohn’s disease Ileocolic resection Mesentery Postoperative recurrence |
url |
http://link.springer.com/article/10.1186/s13063-020-4105-x |
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