Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision for Crohn's Disease
NCT ID: NCT03769922
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
116 participants
INTERVENTIONAL
2019-02-18
2025-01-31
Brief Summary
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Detailed Description
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EME means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.
LME represents that the mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Extensive mesenteric resection
Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.
Extensive mesenteric resection
The mesentery is resected avoiding the root region.
Limited mesenteric excision
Mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).
Limited mesenteric excision
The mesentery is retained.
Interventions
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Extensive mesenteric resection
The mesentery is resected avoiding the root region.
Limited mesenteric excision
The mesentery is retained.
Eligibility Criteria
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Inclusion Criteria
* Patients with a documented history of Crohn's disease based on endoscopic, radiological, or histological criteria
Exclusion Criteria
* Previous ileocolic resection history
* Patients having Crohn's disease lesion at a gastrointestinal site other than the terminal ileum cecum, or right colon
* Patients having an internal fistula which required resection of another segment of bowel
16 Years
65 Years
ALL
No
Sponsors
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University Hospital of Limerick
OTHER
The Cleveland Clinic
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Sir Run Run Shaw Hospital
OTHER
Jinling Hospital, China
OTHER
Responsible Party
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Weiming Zhu
Chief of general surgery
Principal Investigators
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Zhu Weiming
Role: PRINCIPAL_INVESTIGATOR
Jinling Hospital, Nanjing, China.
John Calvin Coffey
Role: PRINCIPAL_INVESTIGATOR
University Hospital Limerick, Limerick, Ireland.
Luca Stocchi
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Yi Li
Role: primary
References
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Coffey CJ, Kiernan MG, Sahebally SM, Jarrar A, Burke JP, Kiely PA, Shen B, Waldron D, Peirce C, Moloney M, Skelly M, Tibbitts P, Hidayat H, Faul PN, Healy V, O'Leary PD, Walsh LG, Dockery P, O'Connell RP, Martin ST, Shanahan F, Fiocchi C, Dunne CP. Inclusion of the Mesentery in Ileocolic Resection for Crohn's Disease is Associated With Reduced Surgical Recurrence. J Crohns Colitis. 2018 Nov 9;12(10):1139-1150. doi: 10.1093/ecco-jcc/jjx187.
Li Y, Zhu W, Gong J, Zhang W, Gu L, Guo Z, Cao L, Shen B, Li N, Li J. Visceral fat area is associated with a high risk for early postoperative recurrence in Crohn's disease. Colorectal Dis. 2015 Mar;17(3):225-34. doi: 10.1111/codi.12798.
Li Y, Ge Y, Gong J, Zhu W, Cao L, Guo Z, Gu L, Li J. Mesenteric Lymphatic Vessel Density Is Associated with Disease Behavior and Postoperative Recurrence in Crohn's Disease. J Gastrointest Surg. 2018 Dec;22(12):2125-2132. doi: 10.1007/s11605-018-3884-9. Epub 2018 Jul 24.
Li Y, Mohan H, Lan N, Wu X, Zhou W, Gong J, Shen B, Stocchi L, Coffey JC, Zhu W. Mesenteric excision surgery or conservative limited resection in Crohn's disease: study protocol for an international, multicenter, randomized controlled trial. Trials. 2020 Feb 21;21(1):210. doi: 10.1186/s13063-020-4105-x.
Other Identifiers
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2018NZKY-025-02
Identifier Type: -
Identifier Source: org_study_id
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