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

A

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

Status

Completed

Conditions

Crohn's Disease

Treatments

Procedure: Mesenteric sparing ileocolic resection
Procedure: Central mesenterectomy ileocolic resection

Study type

Interventional

Funder types

Other

Identifiers

NCT04538638
NL61632.018.18

Details and patient eligibility

About

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.

Full 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.

Enrollment

139 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

139 participants in 2 patient groups

Mesenteric Sparing ileocolic resection
Active Comparator group
Description:
Standard procedure for CD, ileocolic resection without removal of the mesentery.
Treatment:
Procedure: Mesenteric sparing ileocolic resection
Central mesenterectomy ileocolic resection
Active Comparator group
Description:
Experimental procedure for CD: ileocolic resection in which the mesentery is taken up to the level of the ileocolic trunc.
Treatment:
Procedure: Central mesenterectomy ileocolic resection

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Christianne J Buskens

Data sourced from clinicaltrials.gov

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