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CompletedNCT04538638SPICYUpdated Dec 26, 2023

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

An interventional study of Mesenteric sparing ileocolic resection and Central mesenterectomy ileocolic resection in Crohn's Disease, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 1 site in Netherlands. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-12-26.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2020, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
139
Allocation
Randomized
Ages
16 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Crohn's Disease

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Keywords

  • Crohn's Disease
  • Ileocolic
  • Mesenteric Sparing
  • Extended Mesenterectomy
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In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 139 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
139 participants (actual)

Study arms

  • Active comparator
    Mesenteric Sparing ileocolic resection

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

    Procedure: Mesenteric sparing ileocolic resection

  • Active comparator
    Central mesenterectomy ileocolic resection

    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

  • ProcedureMesenteric sparing ileocolic resection

    Mesentery left in situ

  • ProcedureCentral mesenterectomy ileocolic resection

    Mesentery is taken up to the level of the ileocolic trunk

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What researchers measure

Primary outcomes

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

    Time frame: 6 months after surgery

Secondary outcomes

  1. Postoperative morbidity

    Number of patients with Postoperative morbidity

    Time frame: 30 days after surgery

  2. Clinical recurrence rate following ileocolic resection

    Number of patients with Clinical recurrence rate following ileocolic resection

    Time frame: 1 year after surgery

  3. 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

    Time frame: 1 year after surgery

  4. 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.

    Time frame: 5 years

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Study locations

1 site
  • Amsterdam UMC - Location AMC
    Amsterdam, Meibergdreef 9 1105 AZ, Netherlands
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References and documents

Publications

  • 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. PubMed 35171266 ↗

Study documents

  • Statistical analysis plan · Jul 1, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04538638
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Responsible party
Willem A. Bemelman (Full professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
Sep 4, 2020
Start date
Mar 1, 2020
Primary completion
May 1, 2023
Completion
Nov 27, 2023
Last update
Dec 26, 2023

Study contacts

Christianne J Buskens
principal investigator · Amsterdam UMC, location AMC
Willem A Bemelman
principal investigator · Amsterdam UMC, location AMC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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