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

Not Applicable

Completed

• Conditions: Postoperative Disease Recurrence; Crohns Disease
• Interventions: Procedure: mesenteric excision

• Registration Number: NCT02542904
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Primary Completion: 2017-09-01
• Status Verified: 2018-09
• Study Completion: 2018-09-01
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EME	mesenteric excision	the anastomosis was performed as a stapled side-to-side anastomosis with extensive excision of mesenteric tissue.
LME	mesenteric excision	the anastomosis was performed as stapled side-to-side with local excision of the mesenteric tissue adjacent to the diseased bowel

Primary Outcome Measures

Name	Time	Method
postoperative endoscopic recurrence	12 months

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China