KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease - Trial NCT05974358
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Study Focus
Sponsor & Location
Centre Hospitalier Universitaire de Besancon
Timeline & Enrollment
N/A
Jan 01, 2024
Jan 31, 2028
Primary Outcome
endoscopy score
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05974358
Non-Device Trial