ZonMw Funding for Nationwide RCT Comparing Local Excision Techniques for Early Rectal Cancer (ENSURE Study)

We are delighted to announce that our team has received nearly €800,000 in funding from ZonMw for a new nationwide randomised controlled trial (RCT). The ENSURE study will compare two local excision techniques for the treatment of suspected deep submucosal invasive rectal cancer: endoscopic intermuscular dissection (EID) and transanal minimally invasive surgery (TAMIS).

The number of patients with early-stage rectal cancer (cT1-2N0M0) has increased significantly in recent years, largely due to the national colorectal cancer screening programme. This growing patient population requires evidence-based guidance on optimal treatment approaches for suspected deep submucosal invasive rectal cancer.

The trial will include 246 patients who will be monitored for three years, with the aim of improving both oncological and functional outcomes. The primary outcome is the complete (R0) resection rate. Secondary endpoints include bowel function, quality of life, the impact on completion surgery (if indicated) and healthcare costs associated with each technique. We look forward to sharing our results and contributing to more effective, patient-centred treatment strategies for early-stage rectal cancer.