Ileostomy versus fecal diversion device to protect anastomosis after rectal surgery: a randomized clinical trial

Patients with rectal anastomosis commonly experience various ileostomy-related complications. This study aimed to elucidate the usefulness of a fecal diversion device (FDD) as an alternative to ileostomy for protecting rectal anastomosis.

Patients with rectal anastomosis were randomly assigned to the ileostomy and FDD groups except in cases of emergency surgery. The primary endpoint was the clinical safety and effectiveness of FDD. The mean operation time, delay of diet advancement, length of hospital stay, FDD and stoma durations, and anastomotic leakage (AL) management methods were compared.

A total of 54 patients were enrolled in this study. No cases of mortality occurred. Overall morbidity was similar between groups (P = 0.551). Six patients (22.2%) in the FDD group and nine (29.0%) in the stoma group (P = 0.555) had AL. The mean total hospital stay was 16.4 ± 6.7 and 23.4 ± 8.7 days in the FDD and stoma groups, respectively (P = 0.002). The mean total hospital cost was 12,726.8 ± 3422.8 USD and 17,954.9 ± 9040.3 USD in the FDD and stoma groups, respectively (P = 0.008). The mean FDD and stoma durations were 21.6 ± 6.1 days and 114.9 ± 41.3 days, respectively (P < 0.0001).

This study demonstrated FDD safety and effectiveness. We identified the possibility of FDD as an alternative technique to conventional stoma procedures.