Crohn Disease
Conditions
Keywords
Crohn's disease, Kono-S anastomosis, conventional anastomosis, endoscopic recurrence
Brief 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.
Interventions
PROCEDUREKono-S anastomosis
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).
PROCEDUREConventional anastomosis for ileocolonicresection of Crohn's disease
conventional anastomosis for ileocolonicresection of Crohn's disease
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
prospective, multicenter,randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patient ≥ 18 years and ≤75 years * With Crohn's disease. * Requiring a first ileocolonic resection: fistulizing, abscessed, or stenosing disease or disease refractory to medical treatment. * Affiliated to the French social security system.
Exclusion criteria
* Previous ileocolonic resection * Contraindication to postoperative endoscopy. * Anastomosis with a planned defunctioning protective stoma. * Emergency surgery (peritonitis). * Lack of consent to the study. * Pregnant patients. * Refusal to participate or inability to provide informed consent. * Patient under legal protection (individuals under guardianship by court order)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endoscopy score | Month 6 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harvey-Bradshaw Index (HBI) | Month 6 | 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 |
| Crohn's Disease Activity Index (CDAI) clinical scores | Month 6 | 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). |
| Fecal calprotectin | Month 6 | Fecal calprotectin |
Countries
France
Contacts
Primary ContactZaher LAKKIS
Backup ContactAstrid POZET
Outcome results
None listed