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

Not Applicable

Recruiting

• Conditions: Postoperative Surgical Recurrence
• Interventions: Procedure: Limited mesenteric excision; Procedure: Extensive mesenteric resection

• Registration Number: NCT03769922
• Lead Sponsor: Jinling Hospital, China

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Status Verified: 2019-02
• Study Start: 2019-02-18
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27
• Primary Completion: 2024-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Limited mesenteric excision	Limited mesenteric excision	Mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).
Extensive mesenteric resection	Extensive mesenteric resection	Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.

Primary Outcome Measures

Name	Time	Method
Accumulated 5-year postoperative surgical recurrence	5 years after the first surgery	The requirement for repeat surgery for a Crohn's disease related indication.

Secondary Outcome Measures

Name	Time	Method
Accumulated 5-year endoscopic recurrence	5 years after the first surgery	Disease proximal to the anastomosis or in the perianastomotic are considered to be a endoscopic recurrence (Rutgeert's score i2, or higher, disease in other sites is not considered recurrence)
Accumulated 5-year clinical recurrence	5 years after the first surgery	The presence of endoscopic disease (i2, or higher) or radiological evidence plus the presence of symptoms attributable to Crohn's disease that are severe enough to require medical or surgical treatment.

Trial Locations

Locations (1)

General Hospital of Eastern Theater Command; 🇨🇳 Nanjing, Jiangsu, China