Evaluating Safety and Effectiveness of the COLO-BT Device Compared to Protective Ileostomy After Colorectal Surgery

What this Trial Is About

Researchers are evaluating the COLO-BT device as an alternative to the protective ileostomy for patients undergoing colorectal surgery. This study aims to assess the safety and effectiveness of COLO-BT, a temporary intraluminal bypass device designed to reduce contact of fecal content with the surgical anastomotic site. The goal is to avoid stoma creation in most patients, except those whose anastomoses have not healed after surgery, potentially allowing faster and safer recovery. Participants are randomly assigned to one of two groups those receiving the COLO-BT device during colorectal surgery and those receiving the standard protective stoma. The COLO-BT device is removable and intended to temporarily bypass the anastomosis, postponing or avoiding stoma creation when possible. The study compares these two approaches to evaluate their outcomes over a 24-week period after surgery. During the study, participants will be monitored for anastomotic healing and whether stoma creation can be avoided. Researchers will assess the primary outcome of study success, defined as avoidance of ostomy within 24 weeks. Participants will undergo follow-up evaluations and comply with study procedures, including blood transfusion if required. The overall study duration spans from surgery through 24 weeks of monitoring to evaluate safety and effectiveness.

Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy