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Extensive Mesenteric Excision (EME) Versus Local Mesenteric Excision (LME) for Crohn's Disease

Primary Purpose

Postoperative Disease Recurrence, Crohns Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mesenteric excision
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Disease Recurrence

Eligibility Criteria

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

Inclusion Criteria:

  • Crohn's disease limited to the distal ileum and/or right colon

Exclusion Criteria:

  • Concomitant anastomosis/strictureplasty at another site of the gastrointestinal tract, and required a temporary fecal diversion

Sites / Locations

  • Jinling Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LME

EME

Arm Description

the anastomosis was performed as stapled side-to-side with local excision of the mesenteric tissue adjacent to the diseased bowel

the anastomosis was performed as a stapled side-to-side anastomosis with extensive excision of mesenteric tissue.

Outcomes

Primary Outcome Measures

postoperative endoscopic recurrence

Secondary Outcome Measures

Full Information

First Posted
September 4, 2015
Last Updated
September 6, 2018
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02542904
Brief Title
Extensive Mesenteric Excision (EME) Versus Local Mesenteric Excision (LME) for Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

5. Study Description

Brief Summary
Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric resection group and local mesenteric resection group.
Detailed Description
Randomization was performed intraoperatively once the surgeon had determined that there were no other sites of disease and that either type of anastomosis could be performed safely. Computer generated randomization was carried out within strata using randomized permuted blocks to ensure balance of the groups. All surgery was performed by a single group of surgeons experienced in the surgical treatment of Crohn's disease. Surgery was performed open or laparoscopically depending on patient factors and surgeon preference. The resection was performed grossly normal resection margins, with side-to-side anastomosis. The presence of mesenteric marginal thickening with confirmation by naked eye assessment of the mucosal aspect of the bowel were used to establish the limits of the disease.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LME
Arm Type
Active Comparator
Arm Description
the anastomosis was performed as stapled side-to-side with local excision of the mesenteric tissue adjacent to the diseased bowel
Arm Title
EME
Arm Type
Active Comparator
Arm Description
the anastomosis was performed as a stapled side-to-side anastomosis with extensive excision of mesenteric tissue.
Intervention Type
Procedure
Intervention Name(s)
mesenteric excision
Primary Outcome Measure Information:
Title
postoperative endoscopic recurrence
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Crohn's disease limited to the distal ileum and/or right colon Exclusion Criteria: Concomitant anastomosis/strictureplasty at another site of the gastrointestinal tract, and required a temporary fecal diversion
Facility Information:
Facility Name
Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

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Extensive Mesenteric Excision (EME) Versus Local Mesenteric Excision (LME) for Crohn's Disease

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