Crohn's Disease Clinical Trial
— SPICYOfficial title:
Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease
Verified date | December 2023 |
Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 139 |
Est. completion date | November 27, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC - Location AMC | Amsterdam | Meibergdreef 9 |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection | 6 months after surgery | ||
Secondary | Postoperative morbidity | Number of patients with Postoperative morbidity | 30 days after surgery | |
Secondary | Clinical recurrence rate following ileocolic resection | Number of patients with Clinical recurrence rate following ileocolic resection | 1 year after surgery | |
Secondary | 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 | |
Secondary | 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 |
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