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

NCT ID: NCT02542904

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-09-01

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.

Conditions

Postoperative Disease Recurrence; Crohns Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

LME

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

Group Type: ACTIVE_COMPARATOR

mesenteric excision

Intervention Type: PROCEDURE

EME

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

Group Type: ACTIVE_COMPARATOR

mesenteric excision

Intervention Type: PROCEDURE

Interventions

mesenteric excision

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Zhu Weiming

Jinling Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jinling Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

EME vs. LME

Identifier Type: -

Identifier Source: org_study_id