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| ID | Type | Description | Link |
|---|---|---|---|
| NL81981.018.22 | Other Identifier | CCMO |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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The aim of this multicenter randomised controlled trial is to compare the handsewn (end-to-end and Kono-S) to the stapled side-to-side ileocolic anastomosis after ileocolic resection for Crohn's disease with respect to 6 months endoscopic recurrence, functional outcome and health care consumption.
Within the surgical IBD society there has been a lot of attention to technical aspects of ileocolic resection aiming to reduce recurrent Crohn's disease after surgery. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection e.g., handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. It is hypothesised that patients who had an end to end reconstruction will have less endoscopic recurrence (less overscoring, and less stases), a better function and consequently health care consumption than the stapled side to side anastomosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stapled side-to-side anastomosis | Active Comparator | Standard procedure for CD, ileocolic resection with side-to-side anastomosis is done according to local practice with a linear stapler either aniso- or isoperistaltic as advised by the ECCO guidelines |
|
| Handsewn anastomosis: handsewn end-to-end or Kono-s anastomosis | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stapled side-to-side anastomosis | Procedure | Standard procedure for CD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative endoscopic recurrence at 6 months | The postoperative endoscopic recurrence at 6 months following ileocolic resection defined as Rutgeerts > i2b by central reading | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative 30 days complications | 30 days after surgery | |
| Histologic and clinical recurrence rate at 6 months following ileocolic resection | 6 months after surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anouck EG Haanappel, MD | Contact | 0031650828323 | a.e.g.haanappel@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| W.A. Bemelman, Prof. dr. | Amsterdam UMC, location AMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flevoziekenhuis | Recruiting | Almere Stad | Flevoland | 1315 RA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38408943 | Derived | Haanappel AEG, Bellato V, Buskens CJ, Armuzzi A, van der Bilt JDW, de Boer NKH, Danese S, van der Does de Willebois EML, Duijvestein M, van der Horst D, Pellino G, Richir MC, Selvaggi F, Spinelli A, Vignali A, Rosati R, Bemelman WA. Optimising surgical anastomosis in ileocolic resection for Crohn's disease with respect to recurrence and functionality: two international parallel randomized controlled trials comparing handsewn (END-to-end or Kono-S) to stapled anastomosis (HAND2END and the End2End STUDIES). BMC Surg. 2024 Feb 26;24(1):71. doi: 10.1186/s12893-024-02340-3. |
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Randomised controlled trial. Patients with Crohn's disease will be randomised in a 1:2 ratio for stapled side-to-side anastomose versus handsewn anastomosis (either end-to-end or Kono-S) 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.
| Handsewn anastomosis |
| Procedure |
handsewn end-to-end or Kono-s anastomosis |
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| Number of patients in need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence |
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| 1 year after surgery |
| The 5 year reoperation rate for recurrence of disease at the anastomotic site. | 5 year |
| Inflammatory Bowel Disease Questionnaire (IBDQ) | Quality of life measured with IBD questionnaire | 1 year after surgery |
| Hospital costs | Hospital costs per patients in each group | 1 year after surgery |
| 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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