Идёт набор NCT05974358

KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease

Без фазы С лечением Crohn Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Kono-S anastomosis, Conventional anastomosis for ileocolonicresection of Crohn's disease.
Кому может быть актуально: Состояния в реестре: Crohn Disease. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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.

Обзор

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.

Вмешательства

Процедура 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).
Процедура Conventional anastomosis for ileocolonicresection of Crohn's disease
conventional anastomosis for ileocolonicresection of Crohn's disease

Первичные конечные точки

endoscopy score [Срок оценки: Month 6]

Вторичные конечные точки (10)

Harvey-Bradshaw Index (HBI) [Срок оценки: Month 6]
Harvey-Bradshaw Index (HBI) [Срок оценки: Month 12]
Harvey-Bradshaw Index (HBI) [Срок оценки: Month 18]
Harvey-Bradshaw Index (HBI) [Срок оценки: Month 24]
Crohn's Disease Activity Index (CDAI) clinical scores [Срок оценки: Month 6]
Crohn's Disease Activity Index (CDAI) clinical scores [Срок оценки: Month12]
Crohn's Disease Activity Index (CDAI) clinical scores [Срок оценки: Month18]
Crohn's Disease Activity Index (CDAI) clinical scores [Срок оценки: Month24]
Fecal calprotectin [Срок оценки: Month 6]
Fecal calprotectin [Срок оценки: Month 12]

Критерии участия

Критерии включения

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.