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NCT02542904 Clinical Trial

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

Crohns Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02542904
Other study ID # EME vs. LME
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date September 1, 2018

Study information
Verified date September 2018
Source Jinling Hospital, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric resection group and local mesenteric resection group.

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.

Recruitment information / eligibility
Status Completed
Enrollment 119
Est. completion date September 1, 2018
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• mesenteric excision

Locations
Country Name City State
China Jinling Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative endoscopic recurrence 12 months
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