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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Procedure: Mesenteric sparing ileocolic resection; Procedure: Central mesenterectomy ileocolic resection

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.

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Meibergdreef 9
    • Amsterdam, Meibergdreef 9, Netherlands, 1105 AZ
      • Amsterdam UMC - Location AMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mesenteric Sparing ileocolic resection; Standard procedure for CD, ileocolic resection without removal of the mesentery.	Procedure: Mesenteric sparing ileocolic resection; Mesentery left in situ
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; Mesentery is taken up to the level of the ileocolic trunk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morbidity	Number of patients with Postoperative morbidity	30 days after surgery
Clinical recurrence rate following ileocolic resection	Number of patients with 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	.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.	The 5 year reoperation rate for recurrence of disease at the anastomotic site.	5 years

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Christianne J Buskens, Amsterdam UMC, location AMC; Principal Investigator: Willem A Bemelman, Amsterdam UMC, location AMC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Crohn's Disease; Ileocolic; Mesenteric Sparing; Extended Mesenterectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Enteritis; Ileal Diseases; Crohn Disease; Ileitis
• Other Study ID Numbers: NL61632.018.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No