Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision for Crohn's Disease

Jinling Hospital, China

Status: Enrolling

Conditions: Postoperative Surgical Recurrence

Treatments: Procedure: Extensive mesenteric resection; Procedure: Limited mesenteric excision

Study type: Interventional

Funder types: Other

Identifiers

NCT03769922

2018NZKY-025-02

Details and patient eligibility

About

The study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (EME), when compared to that of limited mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease. Half of participants will receive EME, while the other half will receive LME.

Full description

EME and LME are the two surgical procedures which are commonly used in the treatment of Crohn's disease. However, the areas of the mesenteric tissue resected are different.

EME means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.

LME represents that the mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).

Enrollment: 116 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Crohn's disease limited to the distal ileum and/or right colon receiving their index ileocolonic resection
• Patients with a documented history of Crohn's disease based on endoscopic, radiological, or histological criteria

Exclusion criteria

• Pregnancy or willingness to become pregnant in the following year
• Previous ileocolic resection history
• Patients having Crohn's disease lesion at a gastrointestinal site other than the terminal ileum cecum, or right colon
• Patients having an internal fistula which required resection of another segment of bowel

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Extensive mesenteric resection

Experimental group

Description:

Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.

Treatment:

Procedure: Extensive mesenteric resection

Limited mesenteric excision

Active Comparator group

Description:

Mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).

Treatment:

Procedure: Limited mesenteric excision