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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenteric Sparing ileocolic resection | Active Comparator | Standard procedure for CD, ileocolic resection without removal of the mesentery. |
|
| Central mesenterectomy ileocolic resection | Active Comparator | Experimental procedure for CD: ileocolic resection in which the mesentery is taken up to the level of the ileocolic trunc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenteric sparing ileocolic resection | Procedure | Mesentery left in situ |
|
| Measure | Description | Time Frame |
|---|---|---|
| The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection | 6 months after surgery |
| 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 |
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Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Christianne J Buskens | Amsterdam UMC, location AMC | Principal Investigator |
| Willem A Bemelman | Amsterdam UMC, location AMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC - Location AMC | Amsterdam | Meibergdreef 9 | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35171266 | Background | 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. | |
| 39025100 | Derived | van der Does de Willebois EML, Bellato V, Duijvestein M, van der Bilt JDW, van Dongen K, Spinelli A, D'Haens GR, Mundt MW, Furfaro F, Danese S, Vignali A, Bemelman WA, Buskens CJ; SPICY collaborator group. Effect of mesenteric sparing or extended resection in primary ileocolic resection for Crohn's disease on postoperative endoscopic recurrence (SPICY): an international, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Sep;9(9):793-801. doi: 10.1016/S2468-1253(24)00097-9. Epub 2024 Jul 15. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2023 | Dec 12, 2023 |
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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
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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.
| Central mesenterectomy ileocolic resection | Procedure | Mesentery is taken up to the level of the ileocolic trunk |
|
| 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 |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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