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

Primary Purpose

Crohn's Disease

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Mesenteric sparing ileocolic resection

Central mesenterectomy ileocolic resection

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Ileocolic, Mesenteric Sparing, Extended Mesenterectomy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Amsterdam UMC - Location AMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Mesenteric Sparing ileocolic resection

Central mesenterectomy ileocolic resection

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative morbidity

Histologic and clinical recurrence rate at 6 months following ileocolic resection

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

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

Full Information

NCT ID

NCT04538638

First Posted

August 31, 2020

Last Updated

August 31, 2020

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT04538638

Brief Title

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

Acronym

SPICY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

September 1, 2022 (Anticipated)

Study Completion Date

September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare Provider

Masking Description

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.

Allocation

Randomized

Enrollment

138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mesenteric Sparing ileocolic resection

Arm Type

Active Comparator

Arm Description

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

Arm Title

Central mesenterectomy ileocolic resection

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Mesenteric sparing ileocolic resection

Intervention Description

Mesentery left in situ

Intervention Type

Procedure

Intervention Name(s)

Central mesenterectomy ileocolic resection

Intervention Description

Mesentery is taken up to the level of the ileocolic trunk

Primary Outcome Measure Information:

Title

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

Time Frame

6 months after surgery

Secondary Outcome Measure Information:

Title

Postoperative morbidity

Time Frame

30 days after surgery

Title

Histologic and clinical recurrence rate at 6 months following ileocolic resection

Time Frame

6 months after surgery

Title

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

Time Frame

1 year after surgery

Title

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

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christianne J Buskens

Phone

0031205662771

c.j.buskens@amsterdamumc.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christianne J Buskens

Organizational Affiliation

Amsterdam UMC, location AMC

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Willem A Bemelman

Organizational Affiliation

Amsterdam UMC, location AMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Amsterdam UMC - Location AMC

City

Amsterdam

State/Province

Meibergdreef 9

ZIP/Postal Code

1105 AZ

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eline ML van der Does, MD

Phone

0031205662771

e.vanderdoesdewillebois@amsterdamumc.nl

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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