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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
226
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).
conventional anastomosis for ileocolonicresection of Crohn's disease
CHu de Besançon
Besançon, France
RECRUITINGCHU de Bordeaux
Bordeaux, France
NOT_YET_RECRUITINGCHU de Grenoble
Grenoble, France
NOT_YET_RECRUITINGCHU de Lille Hopital Claude Huriez
Lille, France
NOT_YET_RECRUITINGHCL-Hôpital Lyon Sud
Lyon, France
NOT_YET_RECRUITINGAP-HM Hôpital Nord
Marseille, France
NOT_YET_RECRUITINGCHU de Nançy
Nancy, France
NOT_YET_RECRUITINGCHU de Nantes
Nantes, France
NOT_YET_RECRUITINGAp-HP Hopital St Louis
Paris, France
NOT_YET_RECRUITINGAP-HP Hôpital Européen Georges Pompidou
Paris, France
NOT_YET_RECRUITING...and 5 more locations
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 * 1 \<5 aphthous lesions in the neoterminal ileum * 2 \>5 anastomotic lesions with passable stenosis (skip lesions); or lesions in the area of the anastomosis * 3 diffuse ileitis * 4 diffuse ileitis with deep ulcerations and/or Stenosis
Time frame: Month 6
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
Time frame: Month 6
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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Month24
Fecal calprotectin
Fecal calprotectin
Time frame: Month 6
Fecal calprotectin
Fecal calprotectin
Time frame: Month 12
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