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

Crohn's Disease Clinical Trial

— SPICY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538638
• Other study ID #: NL61632.018.18
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: November 27, 2023

Study information

• Verified date: December 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: November 27, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Ileitis

Intervention

Procedure:
• Mesenteric sparing ileocolic resection
Mesentery left in situ
• Central mesenterectomy ileocolic resection
Mesentery is taken up to the level of the ileocolic trunk

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC - Location AMC	Amsterdam	Meibergdreef 9

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

van der Does de Willebois EML; SPICY study group. Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial. BJS Open. 2022 Jan 6;6(1):zrab136. doi: 10.1093/bjsopen/zrab136. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection		6 months after surgery
Secondary	Postoperative morbidity	Number of patients with Postoperative morbidity	30 days after surgery
Secondary	Clinical recurrence rate following ileocolic resection	Number of patients with Clinical recurrence rate following ileocolic resection	1 year after surgery
Secondary	The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence	.The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence	1 year after surgery
Secondary	The 5 year reoperation rate for recurrence of disease at the anastomotic site.	The 5 year reoperation rate for recurrence of disease at the anastomotic site.	5 years