Mechanical bowel preparation with or without oral antibiotics for rectal resection for cancer (REPCA trial): a study protocol for a multicenter randomized controlled trial

Background There is still a lack of randomized trials assessing the clinical value of mechanical bowel preparation (MBP) and oral antibiotics (OA) before rectal surgery. Existing studies are inconsistent regarding OA. The aim of this study is to examine the role of MBP with or without OA (using Alfa Normix (R)) on postoperative complications in patients undergoing rectal resection for cancer. Methods We are conducting a prospective multicenter randomized controlled trial comparing MBP (Moviprep (R)) with OA (Alfa Normix (R)) versus MBP alone in patients undergoing elective rectal resection for cancer. Patients with rectal or rectosigmoid cancer are randomized in a 1:1 allocation ratio. The primary endpoint is incisional surgical site infection (SSI) assessed within 30 days after surgery. Secondary endpoints are anastomotic leakage (AL), organ/space SSI, other postoperative complications, intraoperative complications, operation time, bowel preparation quality, bowel preparation adherence. Intention-to-treat and per protocol analyses will be performed. Conclusions The results of the REPCA trial will demonstrate whether MBP +OA is superior to MBP alone in rectal cancer surgery. This trial might influence current preoperative practice and improve postoperative outcomes.