Clinical trial NCT04538638: Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease
Official title: Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Ileocolic
Mesenteric Sparing
Extended Mesenterectomy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 139
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with Crohn's disease will be randomised in a 1:1 ratio for mesenteric sparing versus central mesenterectomy when performing an ileocolic resection for Crohn's disease
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Postoperative morbidity
timeFrame: 30 days after surgery
measure: Clinical recurrence rate following ileocolic resection
timeFrame: 1 year after surgery
measure: The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence
timeFrame: 1 year after surgery
measure: The 5 year reoperation rate for recurrence of disease at the anastomotic site.
timeFrame: 5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - Location AMC
state: Meibergdreef 9
Study officials:
affiliation: Amsterdam UMC, location AMC
name: Christianne J Buskens
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location AMC
name: Willem A Bemelman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.