Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision for Crohn's Disease

The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Surgical Recurrence
• Intervention / Treatment: Procedure: Extensive mesenteric resection; Procedure: Limited mesenteric excision

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).

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Yi, PhD; Phone Number: +86 13851843735; Email: liyi.jlh@hotmail.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • General Hospital of Eastern Theater Command

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Extensive mesenteric resection; Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.	Procedure: Extensive mesenteric resection; The mesentery is resected avoiding the root region.
ACTIVE_COMPARATOR: 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).	Procedure: Limited mesenteric excision; The mesentery is retained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accumulated 5-year postoperative surgical recurrence	The requirement for repeat surgery for a Crohn's disease related indication.	5 years after the first surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accumulated 5-year endoscopic recurrence	Disease proximal to the anastomosis or in the perianastomotic are considered to be a endoscopic recurrence (Rutgeert's score i2, or higher, disease in other sites is not considered recurrence)	5 years after the first surgery
Accumulated 5-year clinical recurrence	The presence of endoscopic disease (i2, or higher) or radiological evidence plus the presence of symptoms attributable to Crohn's disease that are severe enough to require medical or surgical treatment.	5 years after the first surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative operation-related complications	30-day postoperative morbidity	30 day

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Collaborators: The Cleveland Clinic; Sixth Affiliated Hospital, Sun Yat-sen University; Sir Run Run Shaw Hospital; University Hospital of Limerick
• Investigators: Principal Investigator: Zhu Weiming, Jinling Hospital, Nanjing, China.; Principal Investigator: John Calvin Coffey, University Hospital Limerick, Limerick, Ireland.; Principal Investigator: Luca Stocchi, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2019
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (ACTUAL): December 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Recurrence; Crohn Disease
• Other Study ID Numbers: 2018NZKY-025-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No