The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer Patients: A Prospective, Multicenter, Open-label, Non-inferiority, Randomized Controlled Study
The goal of this clinical trial is to evaluate the safety and efficiency of stent-based tiverting technique (SDT) versus ileostomy in rectal cancer patients. After the removal of the rectal tumor, participants who are at high risk for anastomotic leakage will either undergo SDT or ileostomies. Researchers will compare SDT to see if SDT could help patients save hospital stays, lower medical costs, and enhance their quality of life, and not alternatively avoid defunction stoma.
• Rectal adenocarcinoma confirmed pathologically.
• Rectal cancer patients with high-risk of anastomotic leakage(AL).
• Age from over 18 to under 80 years.
• Performance status of 0/1 on ECOG (Eastern Cooperative Oncology Group) scale.
• ASA (American Society of Anesthesiology) score class I, II, or III.
• Written informed consent.
⁃ Definition of high-risk of AL (one of them):
• Preoperative body mass index (BMI) ≥30 kg/m2;
• Long-term use of glucocorticoids before surgery (≥2 weeks);
• Poor general condition: Preoperative serum albumin was less than 30.0g/L after supportive treatment; or Preoperative renal replacement therapy (blood purification/hemodialysis) is required; or diabetes;
• Preoperative neoadjuvant radiotherapy;
• Distance between tumor and anal anus (baseline MRI) ≤7cm
• The number of stapler used to cut the rectum during the operation ≥3; or the defect of anastomosis is observed; or Intraoperative leak test was positive.