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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 226
- 试验地点
- 16
- 主要终点
- endoscopy score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
endoscopy score
时间窗: 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
次要结局
- Harvey-Bradshaw Index (HBI)(Month 24)
- Crohn's Disease Activity Index (CDAI) clinical scores(Month24)
- Fecal calprotectin(Month 12)