Early Ileostomy Closure Versus Standard Timing After Restorative Proctectomy for Rectal Cancer in North America A Randomized Controlled Trial

What this Trial Is About

This research aims to evaluate early ileostomy closure EIC in adults with rectal cancer who have undergone restorative proctectomy and creation of a diverting loop ileostomy DLI. The study investigates whether EIC is safe, feasible, and beneficial compared to the traditional late closure method. It will focus on comparing complication severity and also assess quality of life, bowel function, and cost of care in a North American population. Participants who meet eligibility undergo a leak test with flexible sigmoidoscopy and CT scan between post-operative days 7 and 9. Those with a negative test are randomized into two groups one group receives EIC with reversal of their DLI between days 10 and 14 post-surgery, using specific surgical techniques without epidural analgesia, and the other group undergoes standardized late closure no earlier than 12 weeks after surgery. During the study, researchers will monitor complications at multiple time points up to 12 months post-surgery, including comprehensive complication index scores and post-operative ileus occurrence. They will also evaluate recovery using PROMIS 29, bowel function with the LARS score, quality of life using EORTC questionnaires, and healthcare costs. Follow-up assessments occur regularly over the year, with data collected on hospital stays, interventions, and appliance costs to understand the overall impact of early versus traditional ileostomy closure.

Early Ileostomy Closure for Rectal Cancer Patients in North America