Besancon University Hospital Center
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.
Crohn Disease
Kono-S anastomosis
Conventional anastomosis for ileocolonicresection of Crohn's disease
NA
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 226 participants |
| Masking : | DOUBLE |
| Primary Purpose : | TREATMENT |
| Official Title : | KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease: a Superiority Phase III Prospective, Randomized, Multicenter, Double-blind Trial. |
| Actual Study Start Date : | 2025-03 |
| Estimated Primary Completion Date : | 2027-07 |
| Estimated Study Completion Date : | 2029-02 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 75 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Chu de Besanchon
Besançon, France, 25030
NOT YET RECRUITING
Bordeaux University Hospital
Bordeaux, France,
NOT YET RECRUITING
Chu's Grenoble
Grenoble, France,
NOT YET RECRUITING
Lille University Hospital Claude Huriez Hospital
Lille, France,
NOT YET RECRUITING
HCL-Lyon South Hospital
Lyon, France,
NOT YET RECRUITING
AP-HM North Hospital
Marseille, France,
NOT YET RECRUITING
CHU de Nançy
Nancy, France,
NOT YET RECRUITING
Chu Nantes
Nantes, France,
NOT YET RECRUITING
Ap-HP Hopital St Louis
Paris, France,
NOT YET RECRUITING
AP-HP Georges Pompidou European Hospital
Paris, France,
NOT YET RECRUITING
AP-HP Le Kremlin-Bicetre
Paris, France,
NOT YET RECRUITING
AP-HP St Antoine
Paris, France,
NOT YET RECRUITING
chu Rennes
Rennes, France,
NOT YET RECRUITING
Strasbourg HautePierre University Hospital
Strasbourg, France,
NOT YET RECRUITING
Toulouse
Toulouse, France,