Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease

Not Applicable

Completed

• Conditions: Crohn's Disease
• Interventions: Procedure: Mesenteric sparing ileocolic resection; Procedure: Central mesenterectomy ileocolic resection

• Registration Number: NCT04538638
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

The aim of this multicenter randomised controlled trial is to analyse the six month endoscopic recurrence following a mesenteric sparing versus a central mesenterectomy performing an ileocolic resection for CD.

Detailed Description

There is emerging evidence to suggest that Crohn's disease (CD) may be a disease of the mesentery rather than just of the bowel alone. A more extensive central mesenterectomy (up to the level of the ileocolic artery), in order to remove an increased volume of affected mesentery to prevent postoperative CD, has been suggested to lead to beneficial results. It is hypothesised that patients who undergo a central mesenterectomy during an ileocolic resection compared to a mesenteric sparing ileocolic resection will have decreased recurrence rates.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-04
• Primary Completion: 2023-05-01
• Study Completion: 2023-11-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Ileocolic disease with an indication for ileocecal resection
2. Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
3. All patients should have undergone a colonoscopy and MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
4. Ability to comply with protocol.
5. Competent and able to provide written informed consent.
6. Patient must have been discussed in the local MDT

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Inability to give informed consent.
2. patients less than 16 years of age.
3. Patients undergoing repeated ileocolic resection.
4. Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
5. History of cancer < 5 years which might influence patients prognosis
6. Emergent operation.
7. Pregnant or breast feeding.
8. Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesenteric Sparing ileocolic resection	Mesenteric sparing ileocolic resection	Standard procedure for CD, ileocolic resection without removal of the mesentery.
Central mesenterectomy ileocolic resection	Central mesenterectomy ileocolic resection	Experimental procedure for CD: ileocolic resection in which the mesentery is taken up to the level of the ileocolic trunc.

Primary Outcome Measures

Name	Time	Method
The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection	6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative morbidity	30 days after surgery	Number of patients with Postoperative morbidity
Clinical recurrence rate following ileocolic resection	1 year after surgery	Number of patients with Clinical recurrence rate following ileocolic resection
The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence	1 year after surgery	.The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence
The 5 year reoperation rate for recurrence of disease at the anastomotic site.	5 years	The 5 year reoperation rate for recurrence of disease at the anastomotic site.

Trial Locations

Locations (1)

Amsterdam UMC - Location AMC; 🇳🇱 Amsterdam, Meibergdreef 9, Netherlands