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Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) currently affecting one person in a thousand in France. It can lead to numerous digestive complications such as fistulas, abscesses or stenosis. Despite numerous therapeutic advances, the rate of patients requiring surgery remains very high, with approximately 50% requiring at least one surgical intervention at 10 years after disease diagnosis. However, surgical treatment is not curative, the postoperative recurrence rate being very high, from 65 to-90% endoscopic recurrence at 1 year. The ileocolonic anastomosis is the main site of postoperative recurrence currently defined by a Rutgeerts score (≥i2) 6 months after surgery. In 2003, Kono et al. described a new operative technique that could reduce the rate of post-operative recurrence: a termino-terminal ileocolonic anastomosis, anti-mesenteric, with a supporting column to prevent distortion and anastomotic stenosis (Kono-S anastomosis). The study showed no decrease in endoscopic recurrence rate at 1 year (83% vs 79%), but a significant decrease in surgical recurrence rate at 5 years (15% vs 0%). Recently, a randomized Italian monocenter study showed a significant decrease in endoscopic recurrence rate at 6 and 18 months (22.2% versus 62.8% and 25% versus 67.4%), as well as a decrease in clinical recurrence. The limitations of this study are its monocentric nature and the lack of centralization of the endoscopic analysis to assess the primary endpoint. This surgical technique has been performed in some centers for ileocolonic Crohn's surgery since 2020. Nevertheless, the level of evidence remains too low to establish practice recommendations. The KOALA study will be the first prospective, multicenter, randomized study comparing KONO-S anastomosis and conventional anastomosis for ileocolonicresection of Crohn's disease, with blinded and centralized evaluation of recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kono-S group | Experimental | Kono-S group, in which ileocolonic anastomosis will be performed following the technique described by Kono et al. |
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| Control group | Other | Conventional side-to-side ileocolonic anastomosis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kono-S anastomosis | Procedure | Kono et al. described a new operative technique that could reduce the rate of post-operative recurrence: a termino-terminal ileocolonic anastomosis, anti-mesenteric, with a supporting column to prevent distortion and anastomotic stenosis (Kono-S anastomosis). |
| Measure | Description | Time Frame |
|---|---|---|
| endoscopy score | Rutgeerts endoscopy score ≥ i2 (>5 anastomotic lesions with passable stenosis (skip lesions); or lesions in the area of the anastomosis) at 6 months obtained by centralized double reading of filmed endoscopy. I0 no lesions
| Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Harvey-Bradshaw Index (HBI) | Harvey-Bradshaw Index (HBI) Disease not active: <4 ; Mild disease activity: HBI >= 4 and <= 8 ; Moderate disease activity: HBI > 8 and <= 12 ; Severe disease activity: HBI > 12 | Month 6 |
| Harvey-Bradshaw Index (HBI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zaher LAKKIS | Contact | +33381218988 | zlakkis@chu-besancon.fr | |
| Astrid POZET | Contact | +33381218988 | apozet@chu-besancon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHu de Besançon | Recruiting | Besançon | 25030 | France |
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prospective, multicenter,randomized study
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| Conventional anastomosis for ileocolonicresection of Crohn's disease | Procedure | conventional anastomosis for ileocolonicresection of Crohn's disease |
|
Harvey-Bradshaw Index (HBI) Disease not active: <4 ; Mild disease activity: HBI >= 4 and <= 8 ; Moderate disease activity: HBI > 8 and <= 12 ; Severe disease activity: HBI > 12
| Month 12 |
| Harvey-Bradshaw Index (HBI) | Harvey-Bradshaw Index (HBI) Disease not active: <4 ; Mild disease activity: HBI >= 4 and <= 8 ; Moderate disease activity: HBI > 8 and <= 12 ; Severe disease activity: HBI > 12 | Month 18 |
| Harvey-Bradshaw Index (HBI) | Harvey-Bradshaw Index (HBI) Disease not active: <4 ; Mild disease activity: HBI >= 4 and <= 8 ; Moderate disease activity: HBI > 8 and <= 12 ; Severe disease activity: HBI > 12 | Month 24 |
| Crohn's Disease Activity Index (CDAI) clinical scores | Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI < 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (>450). | Month 6 |
| Crohn's Disease Activity Index (CDAI) clinical scores | Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI < 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (>450). | Month12 |
| Crohn's Disease Activity Index (CDAI) clinical scores | Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI < 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (>450). | Month18 |
| Crohn's Disease Activity Index (CDAI) clinical scores | Crohn's Disease Activity Index (CDAI) clinical scores The patients with CD can be divided into asymptomatic remission (CDAI < 150), mild-to-moderate CD (150-220), moderate-to-severe CD (220-450), and severe-fulminant disease (>450). | Month24 |
| Fecal calprotectin | Fecal calprotectin | Month 6 |
| Fecal calprotectin | Fecal calprotectin | Month 12 |
| CHU de Bordeaux | Not yet recruiting | Bordeaux | France |
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| CHU de Grenoble | Not yet recruiting | Grenoble | France |
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| CHU de Lille Hopital Claude Huriez | Not yet recruiting | Lille | France |
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| HCL-Hôpital Lyon Sud | Not yet recruiting | Lyon | France |
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| AP-HM Hôpital Nord | Not yet recruiting | Marseille | France |
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| CHU de Nançy | Not yet recruiting | Nancy | France |
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| CHU de Nantes | Not yet recruiting | Nantes | France |
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| Ap-HP Hopital St Louis | Not yet recruiting | Paris | France |
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| AP-HP Hôpital Européen Georges Pompidou | Not yet recruiting | Paris | France |
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| AP-HP Le Kremlin-Bicetre | Not yet recruiting | Paris | France |
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| AP-HP St Antoine | Not yet recruiting | Paris | France |
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| CHU de Rennes | Not yet recruiting | Rennes | France |
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| CHU de Strasbourg HautePierre | Not yet recruiting | Strasbourg | France |
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| CHU de Toulouse | Not yet recruiting | Toulouse | France |
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| 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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