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

NCT ID: NCT04538638

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-11-27

Brief Summary

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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

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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.

Conditions

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Crohn's Disease

Keywords

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Crohn's Disease Ileocolic Mesenteric Sparing Extended Mesenterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
There is no blinding to the treatment allocation for the treating surgeon. The treatment will be blinded for the treating gastroenterologist, the endoscopist and the participants.

Study Groups

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Mesenteric Sparing ileocolic resection

Standard procedure for CD, ileocolic resection without removal of the mesentery.

Group Type ACTIVE_COMPARATOR

Mesenteric sparing ileocolic resection

Intervention Type PROCEDURE

Mesentery left in situ

Central mesenterectomy ileocolic resection

Experimental procedure for CD: ileocolic resection in which the mesentery is taken up to the level of the ileocolic trunc.

Group Type ACTIVE_COMPARATOR

Central mesenterectomy ileocolic resection

Intervention Type PROCEDURE

Mesentery is taken up to the level of the ileocolic trunk

Interventions

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Mesenteric sparing ileocolic resection

Mesentery left in situ

Intervention Type PROCEDURE

Central mesenterectomy ileocolic resection

Mesentery is taken up to the level of the ileocolic trunk

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Willem A. Bemelman

Full professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christianne J Buskens

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location AMC

Willem A Bemelman

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location AMC

Locations

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Amsterdam UMC - Location AMC

Amsterdam, Meibergdreef 9, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 35171266 (View on PubMed)

van der Does de Willebois EML, Bellato V, Duijvestein M, van der Bilt JDW, van Dongen K, Spinelli A, D'Haens GR, Mundt MW, Furfaro F, Danese S, Vignali A, Bemelman WA, Buskens CJ; SPICY collaborator group. Effect of mesenteric sparing or extended resection in primary ileocolic resection for Crohn's disease on postoperative endoscopic recurrence (SPICY): an international, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Sep;9(9):793-801. doi: 10.1016/S2468-1253(24)00097-9. Epub 2024 Jul 15.

Reference Type DERIVED
PMID: 39025100 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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NL61632.018.18

Identifier Type: -

Identifier Source: org_study_id