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.

What this Trial Is About

Researchers are investigating Crohn's disease, a chronic inflammatory bowel disease that affects many people and often leads to serious digestive complications and a high rate of surgery. This research focuses on comparing two surgical techniques for ileocolonic resection to reduce the risk of disease recurrence after surgery. The study is a prospective, multicenter, randomized, double-blind trial aiming to provide stronger evidence on the effectiveness of the Kono-S anastomosis compared to the conventional method. The trial compares two surgical approaches: the Kono-S anastomosis, which is a specific type of ileocolonic connection designed to prevent distortion and narrowing, and the conventional side-to-side ileocolonic anastomosis. Patients undergoing their first ileocolonic resection for Crohn's disease will be randomly assigned to one of these two groups. The Kono-S technique has shown promise in reducing surgical recurrence rates in earlier studies, but this trial will offer a more rigorous evaluation with blinded and centralized assessments. Participants will be monitored over time with various assessments, including an endoscopy at 6 months to measure recurrence using a standardized score. Clinical activity will also be evaluated through indexes such as the Harvey-Bradshaw Index and Crohn's Disease Activity Index at 6, 12, 18, and 24 months, along with fecal calprotectin tests at 6 and 12 months. The study will help determine which surgical method better reduces disease recurrence and improves patient outcomes over the long term, with total participation lasting at least two years.

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