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

Jinling Hospital, China

Status: Completed

Conditions: Crohns Disease; Postoperative Disease Recurrence

Treatments: Procedure: mesenteric excision

Study type: Interventional

Funder types: Other

Identifiers

NCT02542904

EME vs. LME

Details and patient eligibility

About

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

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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119 participants in 2 patient groups

LME

Active Comparator group

Description:

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

Treatment:

Procedure: mesenteric excision

EME

Active Comparator group

Description:

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

Treatment:

Procedure: mesenteric excision