Comparing Endoscopy-Guided and Routine Biological Treatments to Prevent Crohns Disease Return After Surgery

What this Trial Is About

The trial investigates how to best prevent postoperative endoscopic recurrence in patients with Crohns disease who have undergone ileocolonic resection with anastomosis. Researchers are comparing an endoscopy-driven approach to starting biological therapy only when signs of recurrence appear, versus starting systematic prophylactic biological therapy shortly after surgery. This pragmatic randomized trial aims to assess whether the endoscopy-driven strategy leads to similar rates of disease recurrence and other outcomes at week 86, while also evaluating clinical recurrence, safety, costs, work productivity, and quality of life. Additionally, endoscopic images will be used to develop a new scoring system for postoperative recurrence. Participants are randomly assigned to one of two groups. The systematic prophylaxis group starts biological therapy adalimumab, infliximab, ustekinumab, vedolizumab, or risankizumab within 14 to 40 days post-surgery, with specific dosing schedules depending on the drug. The endoscopy-driven group does not receive therapy until week 30, when an endoscopic evaluation is done those with recurrence then start biological therapy following induction and maintenance dosing. Dose optimization is allowed after week 32 in both groups based on clinical practice and drug monitoring. Randomization is stratified by therapy type and risk factors for recurrence. During the study, participants undergo clinical assessments including endoscopies at week 30 and week 86, blood tests, and monitoring of symptoms and quality of life. Researchers track disease recurrence by endoscopic scores and clinical indices like the Harvey-Bradshaw Index. Safety events, treatment adaptations, healthcare costs, and surgery rates are recorded. Study participation lasts until week 86 after surgery, with ongoing data collection to evaluate treatment impact and outcomes in this Crohns disease population.

Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy