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

Primary Purpose

Postoperative Surgical Recurrence

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Extensive mesenteric resection

Limited mesenteric excision

About this trial

This is an interventional treatment trial for Postoperative Surgical Recurrence

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

General Hospital of Eastern Theater CommandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extensive mesenteric resection

Limited mesenteric excision

Arm Description

Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.

Mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).

Outcomes

Primary Outcome Measures

Accumulated 5-year postoperative surgical recurrence

The requirement for repeat surgery for a Crohn's disease related indication.

Secondary Outcome Measures

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)

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.

Full Information

NCT ID

NCT03769922

First Posted

December 6, 2018

Last Updated

February 25, 2019

Sponsor

Jinling Hospital, China

Collaborators

University Hospital of Limerick, The Cleveland Clinic, Sixth Affiliated Hospital, Sun Yat-sen University, Sir Run Run Shaw Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03769922

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Recruiting

Study Start Date

February 18, 2019 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jinling Hospital, China

Collaborators

University Hospital of Limerick, The Cleveland Clinic, Sixth Affiliated Hospital, Sun Yat-sen University, Sir Run Run Shaw Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Surgical Recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Extensive mesenteric resection

Arm Type

Experimental

Arm Description

Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.

Arm Title

Limited mesenteric excision

Arm Type

Active Comparator

Arm Description

Mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).

Intervention Type

Procedure

Intervention Name(s)

Extensive mesenteric resection

Intervention Description

The mesentery is resected avoiding the root region.

Intervention Type

Procedure

Intervention Name(s)

Limited mesenteric excision

Intervention Description

The mesentery is retained.

Primary Outcome Measure Information:

Title

Accumulated 5-year postoperative surgical recurrence

Description

The requirement for repeat surgery for a Crohn's disease related indication.

Time Frame

5 years after the first surgery

Secondary Outcome Measure Information:

Title

Accumulated 5-year endoscopic recurrence

Description

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)

Time Frame

5 years after the first surgery

Title

Accumulated 5-year clinical recurrence

Description

Time Frame

5 years after the first surgery

Other Pre-specified Outcome Measures:

Title

postoperative operation-related complications

Description

30-day postoperative morbidity

Time Frame

30 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Yi, PhD

Phone

+86 13851843735

liyi.jlh@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhu Weiming

Organizational Affiliation

Jinling Hospital, Nanjing, China.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John Calvin Coffey

Organizational Affiliation

University Hospital Limerick, Limerick, Ireland.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luca Stocchi

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

General Hospital of Eastern Theater Command

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Li

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29309546

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.

Results Reference

background

PubMed Identifier

25307174

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.

Results Reference

background

PubMed Identifier

30043133

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.

Results Reference

background

PubMed Identifier

32085793

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.

Results Reference

derived

Links:

URL

https://academic.oup.com/ibdjournal/article-abstract/21/11/2613/4579250?redirectedFrom=fulltext

Description

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

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