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Completed

NCT Number: NCT04538638

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC - Location AMC

Amsterdam, Meibergdreef 9, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mesenteric sparing ileocolic resection

Procedure

Mesentery left in situ

Central mesenterectomy ileocolic resection

Procedure

Mesentery is taken up to the level of the ileocolic trunk

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

    Time frame: 30 days after surgery

    Number of patients with Postoperative morbidity

  2. Clinical recurrence rate following ileocolic resection

    Time frame: 1 year after surgery

    Number of patients with Clinical recurrence rate following ileocolic resection

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

    Time frame: 1 year after surgery

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

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

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: SPICY

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 4, 2020
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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