Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs.
HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction.
DESIGN Randomised superiority study
POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum
INTERVENTION Kono S and end to end hand sewn anastomosis
USUAL CARE Side to side stapled anastomosis
OUTCOME Endoscopic recurrence (local and central reading) at 6 months
SAMPLE 25% reduction in 2:1 ratio -> 126 + 63 = 189 patients
KEYWORDS Crohn, ileocolic resection, recurrence
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Handsewn ileocolic anastomosis | Experimental | Randomised comparison of handsewn (end-to-end and the Kono-S) with the side-to-side stapled anastomosis. to use a manual anastomosis technique avoiding stapled technique to verify if stapled anastomosis can cause ulcers at endoscopic follow up with systematic overscoring |
|
| Side to side stapled anastomosis | No Intervention | Randomised comparison of handsewn (end-to-end and the Kono-S) with the side-to-side stapled anastomosis. to use a manual anastomosis technique avoiding stapled technique to verify if stapled anastomosis can cause ulcers at endoscopic follow up with systematic overscoring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Handsewn anastomosis | Procedure | To perform hand sewn anastomosis (either end to end or Kono-s) during the reconstruction face of ileocolic resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification. | The comparison of 6 months endoscopic recurrence between local and central reading of recordings of endoscopy using the modified Rutgeerts classification. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | postoperative morbidity measure | 1 year |
| Clinical Recurrence | Clinical and surgical recurrence using Clavien Dindo | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| vittoria bellato, MD | Contact | +447827422840 | vittoria.bellato@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| irccs San Raffaele | Recruiting | Milan | Italy |
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Randomised superiority study
Not provided
Not provided
Not provided
| Inflammatory Bowel Disease Questionnaire (IBDQ) | Quality of life measured with IBD questionnaire | 1 year |
| Hospital Costs | Hospital costs per patient in both groups | 1 year |
| D007410 | Intestinal Diseases |