A Phase III Randomized Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer
GRECCAR 17 will be the first prospective and randomized trial to assess a tailored policy in the use of defunctioning stoma after TME according to the personalized risk of anastomotic leakage. The tailored use of defunctioning stoma after TME for rectal cancer should improve both the quality of life of patients and the anorectal function, without any impact on anastomotic leakage. Moreover, for the healthcare system, this new approach could be a cost-effective strategy, leading to a decrease in healthcare expenses. The main objective is to compare the impact of tailored defunctioning stoma after TME for rectal cancer versus the systematic use of defunctioning stoma on the evolution of the specific Quality Of Life (QLQC30) during the 12 months after surgery.
• Age 18-80 years;
• Rectal adenocarcinoma (histologically proven)
• No metastasis or medical history of colorectal metastasis (M0)
• Patients with rectal cancer \< 12 cm from the anal verge (determined by rectal examination or MRI)
• Patients operated on by mini-invasive TME (laparoscopic, robotic or TaTME);
• With or without neo adjuvant treatment
• Realize a stapling anastomosis \< 7 cm from the anal verge (determined by rectal examination or MRI)
• Patients with expected defunctioning ileostomy
• Appropriate hematologic function: hemoglobin ≥ 10.5 g/dL, leukocytes \> 4000/mm3, blood platelets \> 100,000/mm3);
• Appropriate renal function (serum creatinine \< 15 mg/dL);
• Effective contraception of childbearing age : Male patients and premenopausal women should agree to use two medically validated contraceptive methods (one for the patient et one for the partner) during the study
• Patient affiliated or beneficiary to a health security system;
• Patient and doctor have signed informed consent