KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Kono-S anastomosis, Conventional anastomosis for ileocolonicresection of Crohn's disease.
- Who it may be relevant to
- Registry conditions: Crohn Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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
- Procedure Kono-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). - Procedure Conventional anastomosis for ileocolonicresection of Crohn's disease
conventional anastomosis for ileocolonicresection of Crohn's disease
Primary outcome measures
- endoscopy score [Time frame: Month 6]
Secondary outcome measures (10)
- Harvey-Bradshaw Index (HBI) [Time frame: Month 6]
- Harvey-Bradshaw Index (HBI) [Time frame: Month 12]
- Harvey-Bradshaw Index (HBI) [Time frame: Month 18]
- Harvey-Bradshaw Index (HBI) [Time frame: Month 24]
- Crohn's Disease Activity Index (CDAI) clinical scores [Time frame: Month 6]
- Crohn's Disease Activity Index (CDAI) clinical scores [Time frame: Month12]
- Crohn's Disease Activity Index (CDAI) clinical scores [Time frame: Month18]
- Crohn's Disease Activity Index (CDAI) clinical scores [Time frame: Month24]
- Fecal calprotectin [Time frame: Month 6]
- Fecal calprotectin [Time frame: Month 12]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 15 centers
- CHu de Besançon — Besançon
- CHU de Bordeaux — Bordeaux
- CHU de Grenoble — Grenoble
- CHU de Lille Hopital Claude Huriez — Lille
- HCL-Hôpital Lyon Sud — Lyon
- AP-HM Hôpital Nord — Marseille
- CHU de Nançy — Nancy
- CHU de Nantes — Nantes
- … and 7 more centers
Identifiers
NCT: NCT05974358 · 2023/802