Clinical trial NCT03769922: Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision for Crohn's Disease
Official title: The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Surgical Recurrence
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: University Hospital of Limerick
name: The Cleveland Clinic
name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Sir Run Run Shaw Hospital
First posted: 2018-12-10
Enrollment: 116
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (EME), when compared to that of limited mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease. Half of participants will receive EME, while the other half will receive LME.

Detailed description: EME and LME are the two surgical procedures which are commonly used in the treatment of Crohn's disease. However, the areas of the mesenteric tissue resected are different.

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).

Eligibility criteria: Inclusion Criteria:

* Patients with Crohn's disease limited to the distal ileum and/or right colon receiving their index ileocolonic resection
* Patients with a documented history of Crohn's disease based on endoscopic, radiological, or histological criteria

Exclusion Criteria:

* Pregnancy or willingness to become pregnant in the following year
* 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

Primary outcomes:
measure: Accumulated 5-year postoperative surgical recurrence
timeFrame: 5 years after the first surgery
Secondary outcomes:
measure: Accumulated 5-year endoscopic recurrence
timeFrame: 5 years after the first surgery
measure: Accumulated 5-year clinical recurrence
timeFrame: 5 years after the first surgery
Other outcomes:
measure: postoperative operation-related complications
timeFrame: 30 day
Locations:
city: Nanjing
country: China
facility: General Hospital of Eastern Theater Command
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, Nanjing, China.
name: Zhu Weiming
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Limerick, Limerick, Ireland.
name: John Calvin Coffey
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Luca Stocchi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.