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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-18

Study Completion Date

2025-01-31

Brief Summary

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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

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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).

Conditions

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Postoperative Surgical Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Group Type EXPERIMENTAL

Extensive mesenteric resection

Intervention Type PROCEDURE

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).

Group Type ACTIVE_COMPARATOR

Limited mesenteric excision

Intervention Type PROCEDURE

The mesentery is retained.

Interventions

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Extensive mesenteric resection

The mesentery is resected avoiding the root region.

Intervention Type PROCEDURE

Limited mesenteric excision

The mesentery is retained.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Limerick

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Weiming Zhu

Chief of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Yi, PhD

Role: CONTACT

+86 13851843735

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.

Reference Type BACKGROUND
PMID: 29309546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25307174 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30043133 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32085793 (View on PubMed)

Other Identifiers

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2018NZKY-025-02

Identifier Type: -

Identifier Source: org_study_id

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