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

NCT04538638 | Completed

• 1 other identifier: NL61632.018.18
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Ileocolic; Mesenteric Sparing; Extended Mesenterectomy

Outcome Measures

Primary Outcomes (1)

• The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection

  6 months after surgery

Secondary Outcomes (4)

• Postoperative morbidity

  30 days after surgery

• Clinical recurrence rate following ileocolic resection

  1 year after surgery

• The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence

  1 year after surgery

• The 5 year reoperation rate for recurrence of disease at the anastomotic site.

  5 years

Study Arms (2)

Mesenteric Sparing ileocolic resection

ACTIVE COMPARATOR

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

Procedure: Mesenteric sparing ileocolic resection

Central mesenterectomy ileocolic resection

ACTIVE COMPARATOR

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

Procedure: Central mesenterectomy ileocolic resection

Interventions

Mesenteric sparing ileocolic resection PROCEDURE

Mesentery left in situ

Mesenteric Sparing ileocolic resection

Central mesenterectomy ileocolic resection PROCEDURE

Mesentery is taken up to the level of the ileocolic trunk

Central mesenterectomy ileocolic resection

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Ileocolic disease with an indication for ileocecal resection
• Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
• 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.
• Ability to comply with protocol.
• Competent and able to provide written informed consent.
• Patient must have been discussed in the local MDT

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Inability to give informed consent.
• patients less than 16 years of age.
• Patients undergoing repeated ileocolic resection.
• 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.
• History of cancer \< 5 years which might influence patients prognosis
• Emergent operation.
• Pregnant or breast feeding.
• Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC - Location AMC

Amsterdam, Meibergdreef 9, 1105 AZ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 35171266 BACKGROUND

• 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.

  PMID: 39025100 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Christianne J Buskens

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

• Willem A Bemelman

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: 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

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 4, 2020
• Study Start: March 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: November 27, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)